NCT02012049

Bioequivalence Test for Risperdal 2mg of Janssen Korea

Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

Detailed description

This was a randomized (the study drug is assigned by chance) and open labeled (all people know the identity of the intervention) study. All participants were hospitalized in research rooms and were subsequently restricted in exercise, eating, drinking, smoking and xanthine-beverages until the end of blood collection. Water was allowed to be taken until one hour before drug administration. Participants were randomly assigned into two groups, one group receiving Risperdal OD (investigational drug), and one group receiving Risperdal Quicklet (control drug). On the day of testing, blood was collected from all participants to provide baseline measurements. Subsequently, the study drug was orally administered to the participants, followed by blood collection of a total of 13 time points, up to 24 hours. After the blood collection was finished, participants were discharged after receiving proper guidance and being examined by a psychologist. Following a wash-out period (period when receiving no intervention) of one week, participants were hospitalized once more and crossed over to receive the study drugs following the same procedure above described. The approximate study duration (including the drug administration days and wash-out period) was approximately 10 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Risperdal OD Tab. 2mg	1 tablet Risperdal OD 2 mg administered orally.
DRUG	Risperdal Quicklet Tab. 2mg	1 tablet Risperdal Quicklet Tab. 2mg administered orally.

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2013-12-16
• Last updated: 2013-12-16