Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition

Fasting Clinical Trial

Official title: A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Risperidone Tablet 1 mg With Risperdal® 1 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

Status Completed

Clinical Trial Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult human subjects.

Clinical Trial Description

Objective of this pivotal study was to assess the bioequivalence between Test Product:

Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 48 healthy adult subjects. In each study period, a single 1 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 16 days including washout period of at least 10 days between administrations of study drug in each study period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting

• NCT number: NCT01722201
• Study type: Interventional
• Source: IPCA Laboratories Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Completion date: September 2012