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

This study has been completed.
Sponsor:
Collaborator:
Phoenix International Life Sciences Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00652730
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

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: 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
Experimental: A
Subjects received the Par formulated product under fasting conditions
 Drug: Buspirone HCl
Tablets, 30 mg, single-dose, fasting conditions
Other Name: Buspar
Experimental: B
Subjects received the Par formulated product under fed conditions
 Drug: Buspirone HCl
Tablets, 30 mg, single-dose, fed conditions
Other Name: Buspar
Active Comparator: C
Subjects received the Bristol-Myers Squibb formulated product under fed conditions
 Drug: Buspar
Tablets, 30 mg, single-dose, fed conditions
Other Name: Buspirone HCl

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

No publications provided

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

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
buspirone HCl
fed

Additional relevant MeSH terms:
Buspirone
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013