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

Phase 1

Completed

• Conditions: To Determine Bioequivalence Under Fed Conditions
• Interventions: Drug: Buspirone HCl; Drug: Buspar

• Registration Number: NCT00652730
• Lead Sponsor: Par Pharmaceutical, Inc.

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, 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.

Study Timeline

• Study Start: 1998-07
• Primary Completion: 1998-09
• Study Completion: 1998-09
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Buspirone HCl	Subjects received the Par formulated product under fed conditions
C	Buspar	Subjects received the Bristol-Myers Squibb formulated product under fed conditions
A	Buspirone HCl	Subjects received the Par formulated product under fasting conditions

Primary Outcome Measures

Name	Time	Method
Rate and extent of absorption	24 hours

Trial Locations

Locations (1)

Phoenix International Life Sciences inc; 🇨🇦 St-Laurent, Quebec, Canada