CClinicalTrials.gg
CompletedNCT00652730Updated Sep 26, 2017

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

A Phase 1 interventional study of Buspirone HCl and Buspirone HCl in To Determine Bioequivalence Under Fed Conditions, sponsored by Par Pharmaceutical, Inc.. Completed at 1 site in Canada. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-26.

Sponsored by Par Pharmaceutical, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • To Determine Bioequivalence Under Fed Conditions

Keywords

  • bioequivalence
  • buspirone HCl
  • fed
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    A

    Subjects received the Par formulated product under fasting conditions

    Drug: Buspirone HCl

  • Experimental
    B

    Subjects received the Par formulated product under fed conditions

    Drug: Buspirone HCl

  • Active comparator
    C

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

    Drug: Buspar

Interventions

  • DrugBuspirone HCl

    Tablets, 30 mg, single-dose, fasting conditions

    Also known as: Buspar

  • DrugBuspirone HCl

    Tablets, 30 mg, single-dose, fed conditions

    Also known as: Buspar

  • DrugBuspar

    Tablets, 30 mg, single-dose, fed conditions

    Also known as: Buspirone HCl

05

What researchers measure

Primary outcomes

  1. Rate and extent of absorption

    Time frame: 24 hours

06

Study locations

1 site
  • Phoenix International Life Sciences inc
    St-Laurent, Quebec H4R 2N6, Canada
07

Registry details

Key details

Study ID
NCT00652730
Lead sponsor
Par Pharmaceutical, Inc.
Collaborators
Phoenix International Life Sciences, Inc.
First posted
Apr 4, 2008
Start date
Jul 1998
Primary completion
Sep 1998
Completion
Sep 1998
Last update
Sep 26, 2017

Study contacts

Samuel Surfaty, MD
principal investigator · Phoenix International Life Sciences, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion