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”

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

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: September 1998

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.

Intervention(s) in this Clinical Trial

• Drug: Buspirone HCl
  • Tablets, 30 mg, single-dose, fasting conditions
• Drug: Buspirone HCl
  • Tablets, 30 mg, single-dose, fed conditions
• Drug: Buspar
  • Tablets, 30 mg, single-dose, fed conditions

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Subjects received the Par formulated product under fasting conditions
• Experimental: B
  • Subjects received the Par formulated product under fed conditions
• Active Comparator: C
  • Subjects received the Bristol-Myers Squibb formulated product under fed conditions

Primary Measures

• Rate and extent of absorption
  • Time Frame: 24 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Par Pharmaceutical, Inc.

Overall Clinical Trial Officials and Contacts

Samuel Surfaty, MD Principal Investigator Phoenix International Life Sciences Inc  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652730

Study ID Number: 980564

ClinicalTrials.gov Identifier: NCT00652730

Health Authority: United States: Food and Drug Administration