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

NCT00653419 | Completed Phase 1

• 1 other identifier: 980563
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

bioequivalence; buspirone HCl; fasting

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received the Par formulated product (Buspirone HCl) under fasting conditions

Drug: buspirone HCl

B

ACTIVE COMPARATOR

Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions

Drug: Buspar

Interventions

buspirone HCl DRUG

Tablets, 30 mg, single-dose

Also known as: Buspar

A

Buspar DRUG

Tablets, 30 mg, single-dose

Also known as: buspirone HCl

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Phoenix International Life Sciences, Inc.: collaborator

Study Sites (1)

Phoenix International Life Sciences, Inc.

Saint-Laurent, Quebec, H4R 2N6, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Samuel Serfaty, MD

  Phoenix International Life Sciences, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: June 1, 1998
• Primary Completion: September 1, 1998
• Study Completion: September 1, 1998
• Last Updated: April 4, 2008

Record last verified: 2008-04

Locations

CA (1)