A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.; Drug: Univasc® 15mg Tablets

• Registration Number: NCT00992862
• Lead Sponsor: Paddock Laboratories, Inc.

Brief Summary

The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria

• Positive test results for HIV or Hepatitis B or C
• History of allergy or sensitivity to Moexipril HCl or related drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moexipril HCl 15mg Tablets	Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.	-
Univasc® 15mg Tablets	Univasc® 15mg Tablets	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Pittsburg, Pennsylvania, United States