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Keep this study
Lead
Par Pharmaceutical, Inc.
With
Phoenix International Life Sciences, Inc.
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
Age
18–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions