Trial | NCT00653419  Report issue

Title

Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    buspirone ...

  • Study Participants

    48
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
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
Study Started
Jun 30
1998
Primary Completion
Sep 30
1998
Study Completion
Sep 30
1998
Last Update
Apr 04
2008
Estimate

Drug buspirone HCl

Tablets, 30 mg, single-dose

  • Other names: Buspar

Drug Buspar

Tablets, 30 mg, single-dose

  • Other names: buspirone HCl

A Experimental

Subjects received the Par formulated product (Buspirone HCl) under fasting conditions

B Active Comparator

Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions

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
No Results Posted