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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652730

Enrollment

Registered

2008-04-04

Start date

1998-07-31

Completion date

1998-09-30

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Determine Bioequivalence Under Fed Conditions

Keywords

bioequivalence, buspirone HCl, fed

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.

Interventions

DRUGBuspirone HCl

Tablets, 30 mg, single-dose, fasting conditions

DRUGBuspar

Tablets, 30 mg, single-dose, fed conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Rate and extent of absorption	24 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026