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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 NLM:


Further study details as provided by Paddock Laboratories, Inc.:

Primary Outcome Measures:
  • Bioequivalence specified outcomes [ Designated as safety issue: No ]

Enrollment: 48
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00990301     History of Changes
Other Study ID Numbers: 10630201
Study First Received: October 4, 2009
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014