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

This study has been completed.

First Received: April 1, 2008 No Changes Posted

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	Phoenix International Life Sciences Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00653419

Purpose

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

Condition	Intervention	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: buspirone HCl Drug: Buspar	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets in Healthy Adult Males Under Fasting Conditions Following Administration of a 30 mg Dose

Resource links provided by NLM:

Drug Information available for: Buspirone hydrochloride Buspirone

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and extent of absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	June 1998
Study Completion Date:	September 1998
Primary Completion Date:	September 1998 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects received the Par formulated product (Buspirone HCl) under fasting conditions	Drug: buspirone HCl Tablets, 30 mg, single-dose
B: Active Comparator Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions	Drug: Buspar Tablets, 30 mg, single-dose

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653419

Locations

Canada, Quebec
Phoenix International Life Sciences, Inc.
St-Laurent, Quebec, Canada, H4R 2N6
Phoenix International Life Sciences, Inc.
St-Laurent, Quebec, Canada, H4R 2N6

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Phoenix International Life Sciences Inc

Investigators

Principal Investigator:

Samuel Serfaty, MD

Phoenix International Life Sciences Inc

More Information

No publications provided

Responsible Party:	Par Pharmaceutical Inc. ( Alfred Elvin/Director of Biopharmaceutics )
Study ID Numbers:	980563
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00653419 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
buspirone HCl
fasting

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Pharmacologic Actions
Buspirone
Serotonin Agents
Therapeutic Uses
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009