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

November 21, 2013 updated by: Paddock Laboratories, Inc.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15206
        • Novum Pharmaceutical Research Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets
test drug
Active Comparator: Uniretic® 15mg/25mg Tablets
test drug
reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence specified outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kennedy, M.D., Novum Pharmaceutical Research Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 4, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.

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