Bioequivalence Study of Montelukast 5 mg Chewable

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863654
• Other study ID #: 117012
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2013
• Last updated: June 13, 2017
• Start date: May 16, 2010
• Est. completion date: May 26, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 26, 2010
• Est. primary completion date: May 26, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast 5 mg chewable tablets
Reference product
• Montelukast 5 mg chewable tablets
Test product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (CMAX) of montelukast	Pharmacokinetics	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
Primary	Area under the plasma concentration versus time curve (AUC) of montelukast	Pharmacokinetics	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

External Links

•   Results for study 117012 can be found on the GSK Clinical Study Register.