Last updated: 11/03/2018 19:55:36

Bioequivalence study of Montelukast 5 mg chewable

GSK study ID
117012
See study documents
Clinicaltrials.gov ID
NCT01863654
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Peak Plasma Concentration (CMAX) of montelukast

Timeframe: 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

Timeframe: 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

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Montelukast 5 mg chewable tablets
    • Enrollment:
    32
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    montelukast
    Collaborators
    Not applicable
    Study date(s)
    May 2010 to May 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
    • Healthy, between 18 and 50 years.
    • Alteration of vital signs
    • Not complying with inclusion criteria
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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) -
    Exclusion criteria:
    • 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. 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. -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-26-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 117012 can be found on the GSK Clinical Study Register.
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