At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 77 enrolled
Drug / intervention
losartan potassium (+) hydrochlorothiazide (HCTZ) +2 moredrug
Likely dose
losartan potassium (+) hydrochlorothiazide (HCTZ) 100 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.
An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium, and 1 other intervention for Hypertension. Completed, enrolled 77 participants.
Detailed Summary
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
Primary CompletionMay 2004
Study CompletionJul 2004
First PostedAug 2009
TodayJul 2026
First PostedAug 6, 2009
Enrollment StartApr 1, 2004
Primary CompletionMay 1, 2004
Study CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago
Interventions
losartan potassium (+) hydrochlorothiazide (HCTZ)drug
Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
losartan potassiumdrug
Single dose losartan 100 mg tablet in one of two treatment periods.
hydrochlorothiazide (HCTZ)drug
Single dose HCTZ 12.5 mg capsule in one of two treatment periods.