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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992862
First Posted: October 9, 2009
Last Update Posted: September 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Paddock Laboratories, Inc.
  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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00992862     History of Changes
Other Study ID Numbers: B035302
First Submitted: October 7, 2009
First Posted: October 9, 2009
Last Update Posted: September 26, 2013
Last Verified: October 2009

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