Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 7, 2009
September 24, 2013
Not Provided
Not Provided
Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992862 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions
A Relative Bioavailability Study of Moexipril HCl 15mg Tablets Under Fasting Conditions

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.
  • Drug: Univasc® 15mg Tablets
  • Experimental: Moexipril HCl 15mg Tablets
    Intervention: Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.
  • Active Comparator: Univasc® 15mg Tablets
    Intervention: Drug: Univasc® 15mg Tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00992862
B035302
Not Provided
Not Provided
Paddock Laboratories, Inc.
Not Provided
Principal Investigator: Kennedy, M.D. Novum Pharmaceutical Research Services
Paddock Laboratories, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP