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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653419
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Sponsor:
Collaborator:
Phoenix International Life Sciences, Inc.
Information provided by:
Par Pharmaceutical, Inc.

Study Description
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Brief Summary:
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Condition or disease Intervention/treatment Phase
To Determine Bioequivalence Under Fasting Conditions Drug: buspirone HCl Drug: Buspar Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : June 1998
Actual Primary Completion Date : September 1998
Actual Study Completion Date : September 1998

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


Outcome Measures
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Primary Outcome Measures :
  1. Rate and extent of absorption [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653419


Locations
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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
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Principal Investigator: Samuel Serfaty, MD Phoenix International Life Sciences, Inc.
More Information
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Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT00653419    
Other Study ID Numbers: 980563
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008
Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
buspirone HCl
fasting
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action