Clinical Trials Directory

Trials / Completed

CompletedNCT00835042

Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

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

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 fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

Interventions

TypeNameDescription
DRUGMoexipril HCl/hydrochlorothiazide 15/25 mg tablets1 x 15/25 mg
DRUGUNIRETIC® 15/25 mg tablets1 x 15/25 mg

Timeline

Start date
2003-10-01
Primary completion
2003-11-01
Completion
2003-11-01
First posted
2009-02-03
Last updated
2024-08-20
Results posted
2009-08-18

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00835042. Inclusion in this directory is not an endorsement.