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

NCT ID: NCT00990301

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Subjects Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets

Group Type EXPERIMENTAL

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

Intervention Type DRUG

test drug

Uniretic® 15mg/25mg Tablets

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

test drug

Uniretic® 15mg/25mg Tablets

Intervention Type DRUG

reference drug

Interventions

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

test drug

Intervention Type DRUG

Uniretic® 15mg/25mg Tablets

reference drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paddock Laboratories, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

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Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10630201

Identifier Type: -

Identifier Source: org_study_id