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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652730
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Phoenix International Life Sciences, Inc.
Information provided by:
Par Pharmaceutical, Inc.

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE July 1998
Actual Primary Completion Date September 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
Rate and extent of absorption [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE To Determine Bioequivalence Under Fed Conditions
Intervention  ICMJE
  • Drug: Buspirone HCl
    Tablets, 30 mg, single-dose, fasting conditions
    Other Name: Buspar
  • Drug: Buspirone HCl
    Tablets, 30 mg, single-dose, fed conditions
    Other Name: Buspar
  • Drug: Buspar
    Tablets, 30 mg, single-dose, fed conditions
    Other Name: Buspirone HCl
Study Arms  ICMJE
  • Experimental: A
    Subjects received the Par formulated product under fasting conditions
    Intervention: Drug: Buspirone HCl
  • Experimental: B
    Subjects received the Par formulated product under fed conditions
    Intervention: Drug: Buspirone HCl
  • Active Comparator: C
    Subjects received the Bristol-Myers Squibb formulated product under fed conditions
    Intervention: Drug: Buspar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2008)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1998
Actual Primary Completion Date September 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652730
Other Study ID Numbers  ICMJE 980564
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc
Study Sponsor  ICMJE Par Pharmaceutical, Inc.
Collaborators  ICMJE Phoenix International Life Sciences, Inc.
Investigators  ICMJE
Principal Investigator: Samuel Surfaty, MD Phoenix International Life Sciences, Inc.
PRS Account Par Pharmaceutical, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP