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NCT00990301 Clinical Trial

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

Healthy Clinical Trial

Official title:
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic® 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers Under Fasting Conditions.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00990301
Other study ID # 10630201
Secondary ID
Status Completed
Phase Phase 1
First received October 4, 2009
Last updated November 21, 2013

Study information
Verified date November 2013
Source Paddock Laboratories, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
test drug
• Uniretic® 15mg/25mg Tablets
reference drug

Locations
Country Name City State
United States Novum Pharmaceutical Research Services Pittsburg Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Paddock Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence specified outcomes No
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