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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.
October 7, 2009
October 9, 2009
September 26, 2013
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Bioequivalence according to US FDA guidelines
Same as current
Complete list of historical versions of study NCT00992862 on ClinicalTrials.gov Archive Site
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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
Intervention Model: Crossover Assignment
Masking: None (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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00992862
B035302
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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