Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829894
First received: January 26, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 26, 2009
January 26, 2009
June 2001
July 2001   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal® 1 mg Tablets Administered as a 1 x 1 mg Tablets in Subjects Under Fed Conditions

The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Risperidone
    1 mg Tablet
  • Drug: Risperidone
    1 mg Tablet
    Other Name: Risperdal®
  • Experimental: 1
    Risperidone 1 mg Tablet
    Intervention: Drug: Risperidone
  • Active Comparator: 2
    Risperdal® 1 mg Tablet
    Intervention: Drug: Risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2001
July 2001   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Subjects will be females and/or males, non-smokers, 18 years of age and older.
  • Subjects should read, sign and date an Informed Consent Form prior to any study procedure.
  • Female Subjects will be post-menopausal or surgically sterilezed.
  • Post-menopausal status is defined as absence of menses for the past 12 months,
  • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Exclusion Criteria

Subjects to whom any of the following applies will be excluded from the study:

  • Clinically significant illnesses within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any history or presence of significant Neurological, hepatic, renal, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Subjects who do not tolerate venipuncture.
  • Positive urine drug screen at screening.
  • Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence before screening is required.
  • Positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG abnormalities (clinically significant) (PR interval greater than 225 msec or QTc segment greater than 450 msec) or vital sign abnormalities (systolic blood pressure lower than 100 or over 160 mmHg, or diastolic blood pressure lower than 60 or over 96; or heart rate less than 60 bpm) at screening.
  • Subjects with BMI ≥30.0.
  • History of seizures or other predisposing factors.
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • History of cardiac disease or family history of cardiac disease.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
  • History of allergic reactions to risperidone.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
  • Positive alcohol breath test at screening.

Additional exclusion criteria for female subjects only:

o Positive urine pregnancy test at screening (performed on all females).

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00829894
01173
Not Provided
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Benoit Girard, MD Anapharm
Teva Pharmaceuticals USA
January 2009

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