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. (part of Par Health) · Phase 1, Interventional, and Other

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

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.

Conditions studied

To Determine Bioequivalence Under Fed Conditions

Keywords

bioequivalence
buspirone HCl
fed

In context

Lead sponsor

Par Pharmaceutical, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

First submitted before Par Pharmaceutical, Inc. became part of Par Health.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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: 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity: An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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

What researchers measure

Primary outcomes

Rate and extent of absorption
Time frame: 24 hours

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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.

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Discussion

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