Clinical Trials Directory

Trials / Completed

CompletedNCT01218698

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 Fed 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 Fed Condition

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

Summary

Objective: 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

Interventions

TypeNameDescription
DRUGLosartan Potassium Tablets

Timeline

First posted
2010-10-11
Last updated
2017-10-25

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT01218698. Inclusion in this directory is not an endorsement.