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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
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 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
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014