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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014