NCT00830349

Risperidone 1 mg Tablet in Healthy Subjects Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 tablet under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Risperidone	1 mg Tablet
DRUG	Risperidone	1 mg Tablets

Timeline

• Start date: 2001-06-01
• Primary completion: 2001-07-01
• Completion: 2004-07-01
• First posted: 2009-01-27
• Last updated: 2024-08-19

Locations

1 site across 1 country: Canada