AsthmaPhase 1NCT01863654
Bioequivalence Study of Montelukast 5 mg Chewable
A Phase 1 study testing Montelukast 5 mg chewable tablets in people with Asthma, run by GlaxoSmithKline.
Trial summary
The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable tablets; Merck Sharp \& Dohme). The single dosage was one tablet. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast 5 mg chewable tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2010to 26 May 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
- Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
- Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -
Who cannot join
- Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
- Requirement of any kind of medication during the course of the study, except study medication.
- History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
- Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
- Hospitalization for any cause in the seven months before the beginning of the study.
- Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.
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- Blood donation or loss => 450 ml in the 60 days before the beginning of the study.
- History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment.
- -
About this study
Official title: Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Chewable Tablets of Montelukast 5 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair™, Merck Sharp & Dohme de México, S.A. de C.V.) in Fasting Healthy Volunteers
The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent.
Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable tablets; Merck Sharp \& Dohme). The single dosage was one tablet.
Read more
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
- Conditions
- Asthma
- Being tested
- Montelukast 5 mg chewable tablets
- Keywords
- Bioequivalence, Mexico, Asthma, Montelukast, Chewable
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 5 mg chewable tabletsDrug
Also called Singulair, Merck Sharp & Dohme de Mexico SA de CV
Reference product
Montelukast 5 mg chewable tabletsDrug
Test product
| Study group | Role | What they receive |
|---|---|---|
| A(reference)/B(test) | Experimental | initial administration of reference and cross-over to test Receives: Drug: Montelukast 5 mg chewable tablets |
| B(test)/A(reference) | Experimental | initial administration of test and cross-over to reference Receives: Drug: Montelukast 5 mg chewable tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (CMAX) of montelukast
Pharmacokinetics
Measured: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage
Area under the plasma concentration versus time curve (AUC) of montelukast
Pharmacokinetics
Measured: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study start16 May 2010
- Primary completion26 May 2010
- Study completion26 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863654
- Sponsor's protocol ID
- 117012
- Status last verified
- Jun 2017
- First submitted
- 23 May 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Chewable Tablets of Montelukast 5 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair™, Merck Sharp & Dohme de México, S.A. de C.V.) in Fasting Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01863654
- Acronym / sponsor ID
- 117012
- Conditions
- Asthma
- Keywords
- Bioequivalence, Mexico, Asthma, Montelukast, Chewable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 May 2010 (actual)
- Primary completion
- 26 May 2010 (actual)
- Study completion
- 26 May 2010 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent.
Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable tablets; Merck Sharp \& Dohme). The single dosage was one tablet.
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(reference)/B(test) | Experimental | Drug: Montelukast 5 mg chewable tabletsinitial administration of reference and cross-over to test |
| B(test)/A(reference) | Experimental | Drug: Montelukast 5 mg chewable tabletsinitial administration of test and cross-over to reference |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
- Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
- Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -
Key exclusion criteria (9 listed)
- Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
- Requirement of any kind of medication during the course of the study, except study medication.
- History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
- Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
- Hospitalization for any cause in the seven months before the beginning of the study.
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 |
|---|---|---|
| Montelukast 5 mg chewable tabletsAlso: Singulair, Merck Sharp & Dohme de Mexico SA de CVReference product | Drug | A(reference)/B(test), B(test)/A(reference) |
| Montelukast 5 mg chewable tabletsTest product | Drug | A(reference)/B(test), B(test)/A(reference) |
Primary outcome
Peak Plasma Concentration (CMAX) of montelukast
Time frame: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage
Pharmacokinetics
Area under the plasma concentration versus time curve (AUC) of montelukast
Time frame: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage
Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Results for study 117012 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Montelukast 5 mg chewable tablets in people with Asthma, run by GlaxoSmithKline.
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 3 inclusion and 9 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 15 Jun 2017. 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?
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?
Peak Plasma Concentration (CMAX) of montelukast (time frame: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2017.