A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions

Paddock Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Uniretic® 15mg/25mg Tablets; Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990301

10630201

Details and patient eligibility

About

The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.

Enrollment: 48 patients

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 assessments performed at screening

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets

Experimental group

Treatment:

Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.

Uniretic® 15mg/25mg Tablets

Active Comparator group

Treatment:

Drug: Uniretic® 15mg/25mg Tablets

Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.