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

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653419
• Other study ID #: 980563
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: April 1, 2008
• Start date: June 1998
• Est. completion date: September 1998

Study information

• Verified date: April 2008
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1998
• Est. primary completion date: September 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

Intervention

Drug:
• buspirone HCl
Tablets, 30 mg, single-dose
• Buspar
Tablets, 30 mg, single-dose

Locations

Country	Name	City	State
Canada	Phoenix International Life Sciences, Inc.	St-Laurent	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	Phoenix International Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and extent of absorption		24 hours	No