At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Losartan potassium/Hydrochlorothiazide +1 moredrug
Likely dose
Losartan potassium/Hydrochlorothiazide 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Losartan potassium/Hydrochlorothiazide and Hyzaar® for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
Primary CompletionFeb 2004
First PostedJun 2010
TodayJul 2026
First PostedJun 23, 2010
Enrollment StartJan 1, 2004
Primary CompletionFeb 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.0 years ago
Interventions
Losartan potassium/Hydrochlorothiazidedrug
100/25 mg Tablets
Hyzaar®drug
100/25 mg Tablets