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