NCT01064271

Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition

A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single-dose, Randomized, two-Period, Cross over Study

Detailed description

Randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two risperidone 1 mg tablet formulations under Fed conditions. The test formulation was Dr. Reddy's Laboratories Limited's 1 mg Risperidone tablet, and the reference formulation was Risperdal® (risperidone) 1 mg tablet (Janssen Pharmaceutica Products, L.P.). The study was conducted with 26 healthy adults. In each study period, a single 1 mg dose was administered to the subjects following a standardized high-fat breakfast preceded by an overnight fast of at least 10 hours. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Risperidone	Risperidone Tablets 1 mg

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2010-02-08
• Last updated: 2010-02-08