Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00653419 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
To Determine Bioequivalence Under Fasting Conditions | Drug: buspirone HCl Drug: Buspar | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets in Healthy Adult Males Under Fasting Conditions Following Administration of a 30 mg Dose |
Study Start Date : | June 1998 |
Actual Primary Completion Date : | September 1998 |
Actual Study Completion Date : | September 1998 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Subjects received the Par formulated product (Buspirone HCl) under fasting conditions
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Drug: buspirone HCl
Tablets, 30 mg, single-dose
Other Name: Buspar |
Active Comparator: B
Subjects received the Bristol-Myers Squibb formulated product (Buspar) under fasting conditions
|
Drug: Buspar
Tablets, 30 mg, single-dose
Other Name: buspirone HCl |
- Rate and extent of absorption [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | 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:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
- 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 of blood in 14 days (unless approved by 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 within 28 days of study start

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653419
Canada, Quebec | |
Phoenix International Life Sciences, Inc. | |
St-Laurent, Quebec, Canada, H4R 2N6 |
Principal Investigator: | Samuel Serfaty, MD | Phoenix International Life Sciences, Inc. |
Responsible Party: | Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical Inc. |
ClinicalTrials.gov Identifier: | NCT00653419 |
Other Study ID Numbers: |
980563 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | April 4, 2008 |
Last Verified: | April 2008 |
bioequivalence buspirone HCl fasting |
Disease Pathologic Processes Buspirone Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |