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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00990301
First received: October 4, 2009
Last updated: November 21, 2013
Last verified: November 2013

October 4, 2009
November 21, 2013
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Bioequivalence specified outcomes [ Designated as safety issue: No ]
Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990301
10630201
Not Provided
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