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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830349 |
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 tablet under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Risperidone |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal 1 mg Tablets Administered as a 1 x 1 mg Tablet in Healthy Subjects Under Fasting Conditions |
Enrollment: | 30 |
Study Start Date: | June 2001 |
Study Completion Date: | July 2004 |
Primary Completion Date: | July 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Risperidone 1 mg Tablets
|
Drug: Risperidone
1 mg Tablet
|
2: Active Comparator
Risperdal® 1 mg Tablets
|
Drug: Risperidone
1 mg Tablets
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Subjects to whom any of the following applies will be excluded from the study:
Additional exclusion criteria for female subjects only:
Study ID Numbers: | 01172 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830349 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Neurotransmitter Agents Dopamine Tranquilizing Agents Psychotropic Drugs Risperidone |
Central Nervous System Depressants Dopamine Agents Healthy Antipsychotic Agents Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Risperidone Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |