Risperidone 1 mg Tablet in Healthy Subjects Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Risperidone

• Registration Number: NCT00830349
• 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 tablet under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2001-07
• Study Completion: 2004-07
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Risperidone	Risperidone 1 mg Tablets
2	Risperidone	Risperdal® 1 mg Tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC	2 weeks

Trial Locations

Locations (1)

Anapharm Inc.; 🇨🇦 Sainte-Foy, Quebec, Canada