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

September 22, 2017 updated by: Par Pharmaceutical, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • St-Laurent, Quebec, Canada, H4R 2N6
        • Phoenix International Life Sciences inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate and extent of absorption
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Par Pharmaceutical, Inc.

Collaborators

Phoenix International Life Sciences, Inc.

Investigators

  • Principal Investigator: Samuel Surfaty, MD, Phoenix International Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (Actual)

September 1, 1998

Study Completion (Actual)

September 1, 1998

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980564

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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