Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
Information source: Par Pharmaceutical, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: To Determine Bioequivalence Under Fed Conditions.
Intervention: Buspirone HCl (Drug); Buspirone HCl (Drug); Buspar (Drug)
Phase: Phase 1
Sponsored by: Par Pharmaceutical, Inc.
Official(s) and/or principal investigator(s):
Samuel Surfaty, MD, Principal Investigator, Affiliation: Phoenix International Life Sciences Inc
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl
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
Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Rate and extent of absorption
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
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- Medically healthy subjects with clinically normal laboratory profiles will be enrolled
in the study
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or
- 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.
Locations and Contacts
Phoenix International Life Sciences inc, St-Laurent, Quebec H4R 2N6, Canada
Starting date: July 1998
Ending date: September 1998
Last updated: April 1, 2008