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

NCT00652730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-09-26

No results posted yet for this study

Summary

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

Conditions

  • To Determine Bioequivalence Under Fed Conditions

Interventions

DRUG

Buspirone HCl

Tablets, 30 mg, single-dose, fasting conditions

DRUG

Buspirone HCl

Tablets, 30 mg, single-dose, fed conditions

DRUG

Buspar

Tablets, 30 mg, single-dose, fed conditions

Sponsors & Collaborators

  • Phoenix International Life Sciences, Inc.

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Samuel Surfaty, MD · Phoenix International Life Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-07-31
Primary Completion
1998-09-30
Completion
1998-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652730 on ClinicalTrials.gov