CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Moexipril HCl/hydrochlorothiazide 15/25 mg tablets +1 moredrug
Likely dose
Moexipril HCl/hydrochlorothiazide 15/25 mg, 1 tablet (single dose)AI-extracted
Key inclusion· 2
  • ✓Non-smoker at least 18 years of age
  • ✓BMI ≤30
Key exclusion· 9
  • ✕History of chronic alcohol consumption in past 2 years, drug addiction, serious gastrointestinal/renal/hepatic/renal disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma
  • ✕Clinical laboratory test values >20% outside normal range (unless deemed insignificant by investigator)
  • ✕History of allergic responses to moexipril or hydrochlorothiazide class of drugs
  • ✕Positive urine drug screen for any tested substance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00834067
NCT00834067Phase 1Completed
CompareCT.gov

A Relative Bioavailability Study of Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 20, 2024

In Brief

A Phase 1 clinical trial evaluating Moexipril HCl/hydrochlorothiazide 15/25 mg tablets and UNIRETIC® 15/25 mg tablets for Healthy. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking subjects under non-fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartOct 1, 2003
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago

Interventions

Moexipril HCl/hydrochlorothiazide 15/25 mg tabletsdrug

1 x 15/25 mg

UNIRETIC® 15/25 mg tabletsdrug

1 x 15/25 mg