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Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fasting Conditions.

NCT01218711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-10-25

No results posted yet for this study

Summary

Objective:

to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg 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 and Hydrochlorothiazide Tablets

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

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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 NCT01218711 on ClinicalTrials.gov