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

Primary Purpose

To Determine Bioequivalence Under Fed Conditions

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Buspirone HCl

Buspar

About this trial

This is an interventional other trial for To Determine Bioequivalence Under Fed Conditions focused on measuring bioequivalence, buspirone HCl, fed

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Phoenix International Life Sciences inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Subjects received the Par formulated product under fasting conditions

Subjects received the Par formulated product under fed conditions

Subjects received the Bristol-Myers Squibb formulated product under fed conditions

Outcomes

Primary Outcome Measures

Rate and extent of absorption

Secondary Outcome Measures

Full Information

NCT ID

NCT00652730

First Posted

April 1, 2008

Last Updated

September 22, 2017

Sponsor

Par Pharmaceutical, Inc.

Collaborators

Phoenix International Life Sciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00652730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

July 1998 (undefined)

Primary Completion Date

September 1998 (Actual)

Study Completion Date

September 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Par Pharmaceutical, Inc.

Collaborators

Phoenix International Life Sciences, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

To Determine Bioequivalence Under Fed Conditions

Keywords

bioequivalence, buspirone HCl, fed

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Subjects received the Par formulated product under fasting conditions

Arm Title

Arm Type

Experimental

Arm Description

Subjects received the Par formulated product under fed conditions

Arm Title

Arm Type

Active Comparator

Arm Description

Subjects received the Bristol-Myers Squibb formulated product under fed conditions

Intervention Type

Drug

Intervention Name(s)

Buspirone HCl

Other Intervention Name(s)

Buspar

Intervention Description

Tablets, 30 mg, single-dose, fasting conditions

Intervention Type

Drug

Intervention Name(s)

Buspirone HCl

Other Intervention Name(s)

Buspar

Intervention Description

Tablets, 30 mg, single-dose, fed conditions

Intervention Type

Drug

Intervention Name(s)

Buspar

Other Intervention Name(s)

Buspirone HCl

Intervention Description

Tablets, 30 mg, single-dose, fed conditions

Primary Outcome Measure Information:

Title

Rate and extent of absorption

Time Frame

24 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Surfaty, MD

Organizational Affiliation

Phoenix International Life Sciences, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phoenix International Life Sciences inc

City

St-Laurent

State/Province

Quebec

ZIP/Postal Code

H4R 2N6

Country

Canada

12. IPD Sharing Statement

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

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