NCT01149486

Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Losartan potassium/Hydrochlorothiazide	100/25 mg Tablets
DRUG	Hyzaar®	100/25 mg Tablets

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2010-06-23
• Last updated: 2010-12-08
• Results posted: 2010-09-14

Locations

1 site across 1 country: United States