Healthy SubjectsPhase 1NCT03644108

Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers

A Phase 1 study testing Mucinex® ER 600 mg 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.

Trial summary

Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects 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?: Mucinex® ER 600 mg
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: 4 Jun 2009to 15 Jun 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 have been using 1 of the following acceptable birth control methods:
Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days beyond study completion or first menstrual period.
Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion or first menstrual period (whichever is longer).
Stable hormonal contraceptive (e.g., PO, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 through 30 days beyond completion of study or first menstrual period.
Note: Abstinence is not an acceptable form of contraception; however, abstinent female subjects may have been admitted to the study if they agreed, and signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from screening through 30 days beyond completion of the study.

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Females of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1) or postmenopausal >2 years prior to Day 1. A follicle stimulating hormone (FSH) level >40 miU/mL must be obtained and recorded for any postmenopausal females.
Good general health as determined by the PI's 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 had not used nicotine or nicotine-containing products for at least 365 days prior to Day 1.
Able to read, understand, and sign the informed consent form (ICF), after the nature of the study had 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, vital 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 that 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 2 years or excessive alcohol consumption (more than 10 units per week) (1 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 could not 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 were pregnant or nursing.
History of hypersensitivity reaction to guaifenesin.
Receipt of an investigational drug within 30 days prior to Day 1.

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Abnormal diet (for whatever reason) during the 30 days prior to Day 1.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day 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.
Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or human immunodeficiency virus (HIV).

About this study

Official title: A Phase I, Open-label, Single-dose, Single-Period Study to Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-layer Tablet in Normal Healthy Subjects.

Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Conditions: Healthy Subjects
Being tested: Mucinex® ER 600 mg

What participants receive

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

Mucinex® ER 600 mgDrug
Also called guaifenesin
Single dose of Mucinex® 600 mg ER Bi-Layer tablet

Study groups in NCT03644108
Study group	Role	What they receive
Mucinex® ER 600 mg	Experimental	Single dose of Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet taken with 240 mL of water after an overnight fast Receives: Drug: Mucinex® ER 600 mg

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 Parameters Cmax (Maximum observed drug 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, 16 and 24 hours (post-dose) on Day 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).
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, 16 and 24 hours (post-dose) on Day 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the 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, 16 and 24 hours (post-dose) on Day 1 and 2
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Pharmacokinetic Parameter tmax (Time of the maximum observed drug 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, 16 and 24 hours (post-dose) on Day 1 and 2
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. [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, 16 and 24 hours (post-dose) on Day 1 and 2
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.
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, 16 and 24 hours (post-dose) on Day 1 and 2
Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin
Apparent terminal elimination half-life (t1/2) 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, 16 and 24 hours (post-dose) on Day 1 and 2

Secondary outcomes (1)

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Intensity was determined by the Investigator. For symptomatic 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

Timeline

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

4 Jun 200915 Jun 2009

First posted23 Aug 2018
Study start4 Jun 2009
Primary completion15 Jun 2009
Study completion15 Jun 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03644108
Sponsor's protocol ID: 2009-GGE-04
Status last verified: Feb 2019
First submitted: 21 Aug 2018
Last updated: 28 Feb 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 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Single-dose, Single-Period Study to Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-layer Tablet in Normal Healthy Subjects.
ClinicalTrials.gov ID: NCT03644108
Acronym / sponsor ID: 2009-GGE-04
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: 4 Jun 2009 (actual)
Primary completion: 15 Jun 2009 (actual)
Study completion: 15 Jun 2009 (actual)
First posted: 23 Aug 2018 (actual)
Results: Posted 28 Feb 2019

Clinical summary

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

Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mucinex® ER 600 mg	Experimental	Drug: Mucinex® ER 600 mgSingle dose of Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet taken 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 have been using 1 of the following acceptable birth control methods:
Note: Abstinence is not an acceptable form of contraception; however, abstinent female subjects may have been admitted to the study if they agreed, and signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from screening through 30 days beyond completion of the study.
Females of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1) or postmenopausal >2 years prior to Day 1. A follicle stimulating hormone (FSH) level >40 miU/mL must be obtained and recorded for any postmenopausal females.
Good general health as determined by the PI's review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.

Key exclusion criteria (11 listed)

Clinically significant abnormalities detected by medical history, physical examination, vital 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 that 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 2 years or excessive alcohol consumption (more than 10 units per week) (1 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 could not 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 were pregnant or nursing.
History of hypersensitivity 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
Mucinex® ER 600 mgAlso: guaifenesinSingle dose of Mucinex® 600 mg ER Bi-Layer tablet	Drug	Mucinex® ER 600 mg

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, 16 and 24 hours (post-dose) on Day 1 and 2
Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)
Area Under the Plasma Concentration-time Curve From Time 0 to 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, 16 and 24 hours (post-dose) on Day 1 and 2
Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).
Area Under the Plasma Concentration-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, 16 and 24 hours (post-dose) on Day 1 and 2
Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant.
Time to Maximum Observed 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, 16 and 24 hours (post-dose) on Day 1 and 2
Pharmacokinetic Parameter tmax (Time of the maximum observed drug concentration).
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, 16 and 24 hours (post-dose) on Day 1 and 2
Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. [AUCR = AUC(0-t) / AUC(0-inf)]
Apparent 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, 16 and 24 hours (post-dose) on Day 1 and 2
Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.
Apparent 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, 16 and 24 hours (post-dose) on Day 1 and 2
Apparent terminal elimination half-life (t1/2) calculated as ln(2)/Kel.

1 secondary outcome

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 2

Results and safety

Results posted to the registry on 28 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
Mucinex® 600 mg ER	30	30

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, 16 and 24 hours (post-dose) on Day 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Mucinex® 600 mg ER n = 30
Value	876 (45.1)

Population analysed: Data Sets Analyzed as all 30 subjects were included in the guaifenesin concentration tables and the calculation of guaifenesin Pharmacokinetic (PK) parameters.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin

Measure	Mucinex® 600 mg ER n = 30
Value	3670 (45.4)

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin

Measure	Mucinex® 600 mg ER n = 30
Value	3694 (45.2)

Primary outcome: Time to Maximum Observed 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, 16 and 24 hours (post-dose) on Day 1 and 2. Median (Full Range). Unit: hr

Measure	Mucinex® 600 mg ER n = 30
Value	0.752 (0.498 to 2.00)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mucinex® 600 mg ER	0 of 30 (0%)	5 of 30 (16.7%)	5 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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 Mucinex® ER 600 mg 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 11 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 28 Feb 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 28 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, 16 and 24 hours (post-dose) on Day 1 and 2). The study lists 7 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 NCT03644108.

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 28 Feb 2019.