Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting 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 Fasting Conditions
Intervention: buspirone HCl (Drug); Buspar (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Par Pharmaceutical, Inc. Official(s) and/or principal investigator(s):
Samuel Serfaty, MD, Principal Investigator, Affiliation: Phoenix International Life Sciences Inc
Summary
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl
Tablets
Clinical Details
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 design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Rate and extent of absorption
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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Phoenix International Life Sciences, Inc., St-Laurent, Quebec H4R 2N6, Canada
Phoenix International Life Sciences, Inc., St-Laurent, Quebec H4R 2N6, Canada
Additional Information
Starting date: June 1998
Ending date: September 1998
Last updated: April 1, 2008
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