Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
- Registration Number
- NCT00829894
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
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.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Risperidone Risperdal® 1 mg Tablet 1 Risperidone Risperidone 1 mg Tablet
- Primary Outcome Measures
Name Time Method Bioequivalence based on Cmax and AUC 2 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Anapharm Inc.
🇨🇦Sainte-Foy, Quebec, Canada
Anapharm Inc.🇨🇦Sainte-Foy, Quebec, Canada