Status:
COMPLETED
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborating Sponsors:
Phoenix International Life Sciences, Inc.
Conditions:
To Determine Bioequivalence Under Fasting Conditions
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1998
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00653419
Start Date
June 1 1998
End Date
September 1 1998
Last Update
April 4 2008
Active Locations (1)
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1
Phoenix International Life Sciences, Inc.
Saint-Laurent, Quebec, Canada, H4R 2N6