NCT01218022

Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition

An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition

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

Summary

Objective: The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck \& Co., Inc. Study Design: Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Losartan Potassium Tablets

Timeline

• First posted: 2010-10-08
• Last updated: 2017-10-25

Locations

1 site across 1 country: India