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

This study has been completed.
Sponsor:
Collaborator:
Phoenix International Life Sciences Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00653419
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 1, 2008
April 1, 2008
June 1998
September 1998   (final data collection date for primary outcome measure)
Rate and extent of absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
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

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
To Determine Bioequivalence Under Fasting Conditions
  • Drug: buspirone HCl
    Tablets, 30 mg, single-dose
    Other Name: Buspar
  • Drug: Buspar
    Tablets, 30 mg, single-dose
    Other Name: buspirone HCl
  • Experimental: A
    Subjects received the Par formulated product (Buspirone HCl) under fasting conditions
    Intervention: Drug: buspirone HCl
  • Active Comparator: B
    Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions
    Intervention: Drug: Buspar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 1998
September 1998   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00653419
980563
No
Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical Inc.
Par Pharmaceutical, Inc.
Phoenix International Life Sciences Inc
Principal Investigator: Samuel Serfaty, MD Phoenix International Life Sciences Inc
Par Pharmaceutical, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP