NCT01931501

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions

An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets 5mg [Reference Formulation, Merck & Co., Inc. USA] in Healthy Human Volunteers Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5 mg tablet. Dosing periods were separated by a washout period during fasted study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Montelukast Sodium Chewable Tablets 5mg
DRUG	Singulair® (Montelukast Sodium) Chewable Tablets 5mg

Timeline

• Primary completion: 2008-02-01
• First posted: 2013-08-29
• Last updated: 2013-08-29

Locations

1 site across 1 country: India