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Bioequivalence Study of Montelukast 5 mg Chewable

NCT01863654 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-06-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Montelukast 5 mg chewable tablets

Reference product

DRUG

Montelukast 5 mg chewable tablets

Test product

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-16
Primary Completion
2010-05-26
Completion
2010-05-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863654 on ClinicalTrials.gov