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Respiratory DisordersPhase 1NCT02658422

Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions

A Phase 1 study testing Test Montelukast and Reference Montelukast in people with Respiratory Disorders and Asthma and Rhinitis, run by GlaxoSmithKline at 1 site in India.

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

This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under fasting conditions. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Disorders, Asthma and Rhinitis
What is being tested?
Test Montelukast and Reference Montelukast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteIndia
Study dates
18 Aug 2015to 21 Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Healthy, non smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 19 - 24.9 kg/square meter (m^2) (inclusive)
  • Healthy male or female subjects: MALES: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until 24 hours after the last dose of study medication. a.) Vasectomy with documentation of azoospermia. b.) Male condom plus partner use of one of the contraceptive following options: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; and percutaneous contraceptive patches. FEMALES: Eligible to participate, if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a.) Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. b.) Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until 24 hours after the last dose of study medication and completion of the follow-up visit.
  • Capable of giving signed informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Who cannot join

  • Alanine aminotransferase (ALT) and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Corrected QT (QTc) > 450 millisecond (msec) NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read; The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial; For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
  • No concomitant medications should be taken by the subject while participating in the study.
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
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  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
  • Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
  • A positive pre-study drug/alcohol screen.
  • A positive test for Human Immunodeficiency Virus (HIV) antibody.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 90 days.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
  • Any symptoms with a systolic BP <95 millimeter of mercury (mmHg).

Trial locations and contacts

1 site in 1 country.

India1 site

  • GSK Investigational Site

    Telangana, 500 013

Other trials in India

About this study

Official title: An Open-label Balanced, Randomised, Single Dose, Two-way Crossover Study to Determine the Bioequivalence of GW483100 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) Relative to Reference Montelukast Sodium 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) in Healthy Male and Female Volunteers Under Fasting Conditions

This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under fasting conditions. This is an open-label, balanced, randomized, single dose, two-way crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete the study. Each subject enrolled will participate in two treatment periods separated by a washout period of at least 7 days and no more than 14 days between dosing occasions. Total duration in the study for each subject will be approximately 7 weeks from screening to the subject's last visit.

Being tested
Test Montelukast, Reference Montelukast
Medical subject headings
Respiration Disorders, Asthma, Rhinitis

What participants receive

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

  • Test MontelukastDrug

    Test Montelukast (GW483100) is available as round, biconvex, pink 10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water.

  • Reference MontelukastDrug

    Reference Montelukast (innovator product) is available as pale beige, rounded square shaped,10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water. Singular is the innovator product used for this study, which is a trade name owned by Merck Sharp and Dohme Corporation.

Study groups in NCT02658422
Study groupRoleWhat they receive
Sequence A-B (Test Montelukast then Reference Montelukast)ExperimentalSubjects will receive Treatment A- Test montelukast sodium 10 mg tablets (GW483100) in Treatment Period 1 and then Treatment B - Reference montelukast sodium 10 mg tablets (innovator product) in Treatment Period 2.
Receives: Drug: Test Montelukast; Drug: Reference Montelukast
Sequence B-A (Reference Montelukast then Test Montelukast)ExperimentalSubjects will receive Treatment B- Reference montelukast sodium 10 mg tablets (innovator product) in Treatment Period 1 and then Treatment A Test montelukast sodium 10 mg tablets (GW483100) in Treatment Period 2.
Receives: Drug: Test Montelukast; Drug: Reference Montelukast

What is being measured

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

  1. Area under the concentration versus time from time zero to infinity (AUC(0 ∞)) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period

  2. AUC from time zero to last time point with measurable concentration (AUC(0-t)) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period

  3. Maximum observed concentration (Cmax) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period

Secondary outcomes (9)

  1. Time of occurrence of Cmax (tmax) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period.

  2. Percentage of AUC(0-∞) obtained by extrapolation (%AUCex) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period.

  3. Terminal phase half-life (t½) for montelukast in relevant treatments

    Blood samples will be withdrawn on Day 1 and Day 2, and concentrations of montelukast will be determined in plasma samples. Plasma montelukast concentration-time will be analyzed by non-compartmental method and the PK parameters will be derived.

    Measured: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period.

  4. Blood pressure (BP) as a measure of safety and tolerability

    Systolic and diastolic BP will be measured in supine position after 5 minutes rest.

    Measured: 3 days in each treatment period (assessed up to 3 weeks)

  5. Pulse rate measurements as a measure of safety and tolerability

    Pulse rate measurements will be measured in supine position after 5 minutes rest.

    Measured: 3 days in each treatment period (assessed up to 3 weeks)

  6. Number of participants with adverse events (AEs)

    AEs will be collected from the start of study treatment until the subject's last visit.

    Measured: Up to 7 weeks

  7. Composite of hematology parameters as a measure of safety

    Measured: 1 day in Treatment Period 1 and 2 days in Treatment Period 2 (assessed up to 3 weeks)

  8. Composite of clinical chemistry parameters as a measure of safety

    Measured: 1 day in Treatment Period 1 and 2 days in Treatment Period 2 (assessed up to 3 weeks)

  9. Composite of urinalysis parameters as a measure of safety

    Measured: 1 day in Treatment Period 1 and 2 days in Treatment Period 2 (assessed up to 3 weeks)

Timeline

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

  1. First posted18 Jan 2016 (estimated)
  2. Study start18 Aug 2015
  3. Primary completion21 Sep 2015
  4. Study completion21 Sep 2015

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02658422
Sponsor's protocol ID
201681
Status last verified
May 2017
First submitted
6 Jul 2015
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Test Montelukast and Reference Montelukast in people with Respiratory Disorders and Asthma and Rhinitis, run by GlaxoSmithKline at 1 site in India.

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 6 inclusion and 15 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area under the concentration versus time from time zero to infinity (AUC(0 ∞)) for montelukast in relevant treatments (time frame: Samples will be collected at Pre-dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose in each treatment period). The study lists 3 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 NCT02658422.

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 9 May 2017.

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