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

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

Detailed Description
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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.

Official Title
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Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions

Conditions
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To Determine Bioequivalence Under Fed Conditions

Intervention / Treatment
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* Drug: Buspirone HCl
* Drug: Buspirone HCl
* Drug: Buspar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subjects received the Par formulated product under fasting conditions | Drug: Buspirone HCl<br>* Tablets, 30 mg, single-dose, fasting conditions<br>* Other names: Buspar;|
| Experimental: B<br>Subjects received the Par formulated product under fed conditions | Drug: Buspirone HCl<br>* Tablets, 30 mg, single-dose, fed conditions<br>* Other names: Buspar;|
| Active Comparator: C<br>Subjects received the Bristol-Myers Squibb formulated product under fed conditions | Drug: Buspar<br>* Tablets, 30 mg, single-dose, fed conditions<br>* Other names: Buspirone HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and extent of absorption |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, buspirone HCl, fed