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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

NCT01218022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-10-25

No results posted yet for this study

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

DRUG

Losartan Potassium Tablets

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • India

Study Locations

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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 NCT01218022 on ClinicalTrials.gov