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

This study has been completed.
Sponsor:
Information provided by:
Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00992862
First received: October 7, 2009
Last updated: September 24, 2013
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.
Drug: Univasc® 15mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Moexipril HCl 15mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Paddock Laboratories, Inc.:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]

Estimated Enrollment: 60
Arms Assigned Interventions
Experimental: Moexipril HCl 15mg Tablets Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.
Active Comparator: Univasc® 15mg Tablets Drug: Univasc® 15mg Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992862

Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburg, Pennsylvania, United States, 15206
Sponsors and Collaborators
Paddock Laboratories, Inc.
Investigators
Principal Investigator: Kennedy, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00992862     History of Changes
Other Study ID Numbers: B035302
Study First Received: October 7, 2009
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Moexipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014