NCT01928069

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions

An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fed Condition.

• 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 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fed 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 Tablets 10 mg

Timeline

• Primary completion: 2009-12-01
• First posted: 2013-08-23
• Last updated: 2013-08-23

Locations

1 site across 1 country: India