Buspirone Hydrochloride 30mg Tablets, Non-Fasting

Study Description

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Brief Summary:

This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under non-fasting conditions.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: BUSPAR® 30 mg Tablet; Drug: Buspirone Hydrochloride 30 mg Tablet	Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Official Title:	A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Non-Fasting Conditions
Study Start Date :	December 2001
Actual Primary Completion Date :	December 2001
Actual Study Completion Date :	December 2001

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: Buspirone Hydrochloride 30 mg Tablet; 1 x 30 mg, single-dose fed
Active Comparator: 2	Drug: BUSPAR® 30 mg Tablet; 1 x 30 mg, single-dose fed

Outcome Measures

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Primary Outcome Measures :

1. Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30.
• Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.

• The screening clinical laboratory procedures will include:

  • Hematology: hematocrit, hemoglobin, RBC count, WBC count with differential, platelet count;
  • Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase.
  • HIV antibody and hepatitis B surface antigen screens;
  • Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
  • Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine;
  • Serum Pregnancy Screen (female volunteers only).

• If female and:

  • of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
  • is postmenopausal for at least 1 year; or
  • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

• Volunteers with a recent history of drug or alcohol addiction or abuse.
• Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
• Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
• Volunteers demonstrating a positive drug abuse screen when screened for this study.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breastfeeding.
• Volunteers with a history of allergic response(s) to buspirone or related drugs.
• Volunteers with a history of clinically significant allergies including drug allergies.
• Volunteers with a clinically significant illness during 4 weeks prior to Period I dosing (as determined by the clinical investigators).
• Volunteers who are currently using or report using tobacco products within 90 days prior to Period I dosing.
• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
• Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
• Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
• Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
• Volunteers who report taking any prescription medication or nonprescription medication in the 14 days or 7 days, respectively, prior to Period I dosing with the exception of topical products without systemic absorption.
• Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.
• Volunteers who report an intolerance or direct venipuncture.

Contacts and Locations

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Locations

United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

Principal Investigator:	James D. Carlson, Pharm.D.	PRACS Institute, Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00840398 History of Changes
Other Study ID Numbers:	R01-655
First Posted:	February 10, 2009
Last Update Posted:	February 10, 2009
Last Verified:	February 2009

Keywords provided by Teva Pharmaceuticals USA:

Bioequivalence; Healthy Subjects

Additional relevant MeSH terms:

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