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

Paddock Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Univasc® 15mg Tablets; Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992862

B035302

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Moexipril HCl 15mg Tablets

Experimental group

Treatment:

Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.

Univasc® 15mg Tablets

Active Comparator group

Treatment:

Drug: Univasc® 15mg Tablets