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

Par Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: To Determine Bioequivalence Under Fed Conditions

Treatments: Drug: Buspirone HCl; Drug: Buspar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652730

980564

Details and patient eligibility

About

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Full description

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 conditions.

Enrollment: 21 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

A

Experimental group

Description:

Subjects received the Par formulated product under fasting conditions

Treatment:

Drug: Buspirone HCl

Drug: Buspirone HCl

B

Experimental group

Description:

Subjects received the Par formulated product under fed conditions

Treatment:

Drug: Buspirone HCl

Drug: Buspirone HCl

C

Active Comparator group

Description:

Subjects received the Bristol-Myers Squibb formulated product under fed conditions

Treatment:

Drug: Buspar