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A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990301
First Posted: October 6, 2009
Last Update Posted: November 25, 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 (Responsible Party):
Paddock Laboratories, Inc.
October 4, 2009
October 6, 2009
November 25, 2013
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Bioequivalence specified outcomes
Bioequivalence according to US FDA guidelines
Complete list of historical versions of study NCT00990301 on ClinicalTrials.gov Archive Site
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A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic® 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers Under Fasting Conditions.
The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, 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/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
    test drug
  • Drug: Uniretic® 15mg/25mg Tablets
    reference drug
  • Experimental: Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets
    Intervention: Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
  • Active Comparator: Uniretic® 15mg/25mg Tablets
    Interventions:
    • Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
    • Drug: Uniretic® 15mg/25mg 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
48
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Inclusion Criteria:

  • Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening

Exclusion Criteria:

  • Positive test results for HIV or Hepatitis B or C
  • History of allergy or sensitivity to Moexipril, Hydrochlorothiazide 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
 
 
NCT00990301
10630201
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Paddock Laboratories, Inc.
Paddock Laboratories, Inc.
Not Provided
Principal Investigator: Kennedy, M.D. Novum Pharmaceutical Research Services
Paddock Laboratories, Inc.
November 2013

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