Bioequivalence Test for Risperdal 2mg of Janssen Korea

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight)

• Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination

• Participant who was deemed appropriate as a result of inquiry, blood pressure, physical examination, electrocardiogram, blood and urinalysis, etc., within 28 days prior to the first administration of the investigational drug according to the protocol

• Female participant who was confirmed as non-pregnant through urine test during health examination

Exclusion Criteria:

• Participant who had a history of disease related to cardiac, respiratory, hepatic, renal, gastrointestinal or nervous system, or cardiac infarction, stroke, hypertension, arrhythmia, coronary artery disease, or neuropsychiatric diseases that could affect drug absorption, distribution, metabolism and excretion or could be risk factors when taking drugs used for the clinical trial, a history of gastrointestinal surgery except appendectomy or herniotomy, or who currently had abnormality in inquiry or physical examination

• Participant who showed symptoms that were suspected as acute disease within 14 days from the first administration of the investigational drug

• Participant with allergic disease requiring treatment

• Participant who had a history of being hypersensitive to drugs or food

• Patient who had hepatitis B antigen or who showed hepatitis C positive antigen