Bioequivalence Test for Risperdal 2mg of Janssen Korea

Bioequivalence Test for Risperdal OD Tab. 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Risperdal OD Tab. 2mg; Drug: Risperdal Quicklet Tab. 2mg

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risperdal OD / Risperdal Quicklet; Risperdal OD (investigational drug) + Risperdal Quicklet (control drug)	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.
Experimental: Risperdal Quicklet / Risperdal OD; Risperdal Quicklet (control drug) + Risperdal OD (investigational drug)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of Risperidone	Up to 24 hours postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety	Approximately 10 days

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Healthy; Korea; Risperdal OD; Risperdal Quicklet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR016576; RISSCH1015 (Other Identifier: Janssen Korea, Ltd., Korea); RIS-KOR-1083 (Other Identifier: Janssen Korea, Ltd., Korea)