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

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ClinicalTrials.gov Identifier: NCT00990301
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Paddock Laboratories, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. Drug: Uniretic® 15mg/25mg Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
test drug

Active Comparator: Uniretic® 15mg/25mg Tablets Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
test drug

Drug: Uniretic® 15mg/25mg Tablets
reference drug




Primary Outcome Measures :
  1. Bioequivalence specified outcomes


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990301


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

Responsible Party: Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00990301     History of Changes
Other Study ID Numbers: 10630201
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Paddock Laboratories, Inc.:
Healthy Subjects
Bioequivalence

Additional relevant MeSH terms:
Moexipril
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors