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Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions

NCT ID: NCT00653419

Last Updated: 2008-04-04

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

Study Start Date

1998-06-30

Study Completion Date

1998-09-30

Brief Summary

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To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Detailed Description

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To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets under fasting conditions, following administration of a 30 mg dose

Conditions

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To Determine Bioequivalence Under Fasting Conditions

Keywords

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bioequivalence buspirone HCl fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Subjects received the Par formulated product (Buspirone HCl) under fasting conditions

Group Type EXPERIMENTAL

buspirone HCl

Intervention Type DRUG

Tablets, 30 mg, single-dose

B

Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions

Group Type ACTIVE_COMPARATOR

Buspar

Intervention Type DRUG

Tablets, 30 mg, single-dose

Interventions

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buspirone HCl

Tablets, 30 mg, single-dose

Intervention Type DRUG

Buspar

Tablets, 30 mg, single-dose

Intervention Type DRUG

Other Intervention Names

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Buspar buspirone HCl

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers, 18-45 years of age
* Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
* Physical examination and laboratory tests of hematologic, hepatic and renal functions
* Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study

Exclusion Criteria

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
* The presence of alcoholism or drug abuse within the past year
* Hypersensitivity or idiosyncratic reaction to buspirone HCl
* Subjects who have been receiving monoamine oxidase inhibitors
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study
* Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL of blood in 14 days (unless approved by Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year
* Subjects who have participated in another clinical trial within 28 days of study start
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Phoenix International Life Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Par Pharmaceutical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Par Pharmaceutical Inc.

Principal Investigators

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Samuel Serfaty, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix International Life Sciences, Inc.

Locations

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Phoenix International Life Sciences, Inc.

Saint-Laurent, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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980563

Identifier Type: -

Identifier Source: org_study_id