Healthy SubjectsPhase 1NCT03643575

Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.

A Phase 1 study testing Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion and Organ-I- NR tablet in people with Healthy Subjects, run by Reckitt Benckiser Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion and Organ-I- NR tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 30 Jun 2009to 16 Jul 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and/or females between the ages of 19 and 55 years, inclusive.
Females of childbearing potential must be using one of the following acceptable birth control methods:
Intra-uterine device in place for at least 3 months prior to Day 1 of Period 1 through 30 days beyond study completion;
Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion;
Stable hormonal contraceptive (e.g., oral, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 of Period 1 through 30 days beyond completion of study;
Abstinence is not an acceptable form of contraception; however, abstinent female subjects may be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from screening through 30 days beyond completion of the study.

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Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or postmenopausal >2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) concentration >40 miU/mL must be obtained and recorded for any postmenopausal females.
Good general health as determined by the Principal Investigator's (PI) review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.
Within 15% of ideal body weight (Table of 'Desirable Weights of Adults' Metropolitan Life Insurance Company, 1983).
Non-tobacco users, who have not used nicotine or nicotine-containing products for at least 365 days prior to Day 1 of Period 1.
Able to read, understand and sign the informed consent after the nature of the study has been explained.
Negative urine screen for drugs of abuse and alcohol at screening and each check in.
If female, negative finding on serum pregnancy test at screening and each check-in.

Who cannot join

Clinically significant abnormalities detected by medical history, physical examination, vial sign measurements, ECG, or clinical laboratory findings (as determined by the PI/designee) including a hemoglobin value <12 g/dL at screening. If a subject's hemoglobin drops below 11.0 g/dL during the study, the subject may be dropped from the study at the discretion of the PI.
Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drugs (as determined by the PI/designee).
Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) (one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., 'hard' liquor such as gin, whiskey, or vodka, et. al.). The subject is not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
Females who are pregnant or nursing.
History of sensitivity reaction to guaifenesin.
History of or intolerance to lactose.

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Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day 1 of Period 1.
Known or suspected use of illicit drugs.
The use of any medication (with the exception of hormonal contraceptives for women of childbearing potential) for 14 days or 5 half-lives of the drug (whichever is longer) prior to Day 1 of Period 1, if not approved by Investigator.
Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV at Screening.
Subjects who have participated in previous Reckitt Benckiser studies.

About this study

Official title: A Phase I, Open- Label, Randomized, Multiple-dose, 3-way Crossover Relative Bioavailability Study to Characterize the Pharmacokinetics of the 3 Marketed Products Containing 200 mg Guaifenesin Under Fasted Conditions in Normal Healthy Subjects.

Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin

Conditions: Healthy Subjects
Being tested: Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion, Organ-I- NR tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vicks Cough Syrup for Chesty CoughsDrug
Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
Robitussin Extra Strength Chest CongestionDrug
Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
Organ-I- NR tabletDrug
Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water

Study groups in NCT03643575
Study group	Role	What they receive
Treatment A: Vicks Cough Syrup for Chesty Coughs	Experimental	Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast Receives: Drug: Vicks Cough Syrup for Chesty Coughs
Treatment B: Robitussin Extra Strength Chest Congestion	Experimental	Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast Receives: Drug: Robitussin Extra Strength Chest Congestion
Treatment C: Organ-I- NR tablet	Experimental	Organ-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast Receives: Drug: Organ-I- NR tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose
Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose
Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose
Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4.
Cav is calculated as AUC(8-12) / dosing interval, 4
Measured: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose
Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin
T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin
Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin
AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin
AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin
AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours
Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin
AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.
Measured: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf).
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Accumulation Index (AI) of Guaifenesin
AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours
Degree of Fluctuation (DF) of Guaifenesin
DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin
Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss.
Measured: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours

Secondary outcomes (1)

Number of Participants With Adverse Events (AEs)
Intensity was determined by the Investigator. For symptomatic Adverse Events (AEs) the following definitions were applied.
Mild = AE did not limit usual activities; subject may have experienced slight discomfort.
Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.
Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.
Relationship to Investigational Medicinal Products (IMP)
Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Measured: Up to day 2 (Period 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 200916 Jul 2009

First posted23 Aug 2018
Study start30 Jun 2009
Primary completion16 Jul 2009
Study completion16 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03643575
Sponsor's protocol ID: 2009-GGE-05
Status last verified: Mar 2019
First submitted: 21 Aug 2018
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open- Label, Randomized, Multiple-dose, 3-way Crossover Relative Bioavailability Study to Characterize the Pharmacokinetics of the 3 Marketed Products Containing 200 mg Guaifenesin Under Fasted Conditions in Normal Healthy Subjects.
ClinicalTrials.gov ID: NCT03643575
Acronym / sponsor ID: 2009-GGE-05
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Reckitt Benckiser Inc.Industry (pharma, biotech, devices)
Study start: 30 Jun 2009 (actual)
Primary completion: 16 Jul 2009 (actual)
Study completion: 16 Jul 2009 (actual)
First posted: 23 Aug 2018 (actual)
Results: Posted 22 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A: Vicks Cough Syrup for Chesty Coughs	Experimental	Drug: Vicks Cough Syrup for Chesty CoughsVicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast
Treatment B: Robitussin Extra Strength Chest Congestion	Experimental	Drug: Robitussin Extra Strength Chest CongestionRobitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast
Treatment C: Organ-I- NR tablet	Experimental	Drug: Organ-I- NR tabletOrgan-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Males and/or females between the ages of 19 and 55 years, inclusive.
Females of childbearing potential must be using one of the following acceptable birth control methods:
Abstinence is not an acceptable form of contraception; however, abstinent female subjects may be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from screening through 30 days beyond completion of the study.
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or postmenopausal >2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) concentration >40 miU/mL must be obtained and recorded for any postmenopausal females.
Good general health as determined by the Principal Investigator's (PI) review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.

Key exclusion criteria (13 listed)

Clinically significant abnormalities detected by medical history, physical examination, vial sign measurements, ECG, or clinical laboratory findings (as determined by the PI/designee) including a hemoglobin value <12 g/dL at screening. If a subject's hemoglobin drops below 11.0 g/dL during the study, the subject may be dropped from the study at the discretion of the PI.
Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drugs (as determined by the PI/designee).
Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) (one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., 'hard' liquor such as gin, whiskey, or vodka, et. al.). The subject is not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
Females who are pregnant or nursing.
History of sensitivity reaction to guaifenesin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vicks Cough Syrup for Chesty CoughsVicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water	Drug	Treatment A: Vicks Cough Syrup for Chesty Coughs
Robitussin Extra Strength Chest CongestionRobitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water	Drug	Treatment B: Robitussin Extra Strength Chest Congestion
Organ-I- NR tabletOrgan-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water	Drug	Treatment C: Organ-I- NR tablet

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.
Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.
Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).
Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose
Time frame: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4. Cav is calculated as AUC(8-12) / dosing interval, 4
Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.
Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.
Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.
Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase.
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant.
Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours
AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.
Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin
Time frame: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf).
Accumulation Index (AI) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours
AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).
Degree of Fluctuation (DF) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav.
Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin
Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss.

1 secondary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Up to day 2 (Period 3)

Results and safety

Results posted to the registry on 22 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	5	5
Treatment Sequence 2	5	5
Treatment Sequence 3	5	5
Treatment Sequence 4	5	5
Treatment Sequence 5	5	5
Treatment Sequence 6	5	5

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Guaifenesin

Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A n = 26	Treatment B n = 28	Treatment C n = 28
Value	1730 (723)	1230 (456)	1110 (433)

Population analysed: Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period.

Primary outcome: Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose

Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A n = 26	Treatment B n = 28	Treatment C n = 28
Value	876 (548)	765 (309)	796 (317)

Population analysed: PK analyses

Primary outcome: Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose

Time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A n = 26	Treatment B n = 28	Treatment C n = 28
Value	60.3 (33.4)	55.1 (28.0)	73.6 (59.9)

Population analysed: PK analyses

Primary outcome: Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose

Time frame: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A n = 26	Treatment B n = 28	Treatment C n = 28
Value	357 (168)	313 (128)	300 (128)

Population analysed: PK analyses

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to day 2 (Period 3). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29
Treatment B	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Treatment C	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion and Organ-I- NR tablet in people with Healthy Subjects, run by Reckitt Benckiser Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin (time frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.