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

This study has been completed.
Information provided by:
Paddock Laboratories, Inc. Identifier:
First received: October 7, 2009
Last updated: September 24, 2013
Last verified: October 2009
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
Intervention Model: Crossover Assignment
Masking: None (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

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00992862

United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburg, Pennsylvania, United States, 15206
Sponsors and Collaborators
Paddock Laboratories, Inc.
Principal Investigator: Kennedy, M.D. Novum Pharmaceutical Research Services
  More Information Identifier: NCT00992862     History of Changes
Other Study ID Numbers: B035302
Study First Received: October 7, 2009
Last Updated: September 24, 2013

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on September 25, 2017