Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions - Full Text View

Sponsors and Collaborators:	Par Pharmaceutical, Inc. Phoenix International Life Sciences Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00652730

Purpose

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

Condition	Intervention	Phase
To Determine Bioequivalence Under Fed Conditions.	Drug: Buspirone HCl Drug: Buspar	Phase I

Drug Information available for: Buspirone Buspirone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions

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:	21
Study Start Date:	July 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 under fasting conditions	Drug: Buspirone HCl Tablets, 30 mg, single-dose, fasting conditions
B: Experimental Subjects received the Par formulated product under fed conditions	Drug: Buspirone HCl Tablets, 30 mg, single-dose, fed conditions
C: Active Comparator Subjects received the Bristol-Myers Squibb formulated product under fed conditions	Drug: Buspar Tablets, 30 mg, single-dose, fed conditions

Detailed Description:

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.

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.
In addition, 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 blood in 14 days (unless approved by the 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 with 28 days of study start.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652730

Locations

Canada, Quebec
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 Surfaty, MD

Phoenix International Life Sciences Inc

More Information

Responsible Party:	Par Pharmaceutical, Inc ( Alfred Elvin/Director of Biopharmaceutics )
Study ID Numbers:	980564
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00652730
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
buspirone HCl
fed

Study placed in the following topic categories:

Buspirone
Malnutrition
Healthy
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Tranquilizing Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009