NCT01064232

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions. The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica Products, L.P.). The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.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