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History of Changes for Study: NCT02012049
Bioequivalence Test for Risperdal 2mg of Janssen Korea
Latest version (submitted December 10, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 10, 2013 None (earliest Version on record)
Comparison Format:

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Study NCT02012049
Submitted Date:  December 10, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR016576
Brief Title: Bioequivalence Test for Risperdal 2mg of Janssen Korea
Official Title: Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea
Secondary IDs: RISSCH1015 [Janssen Korea, Ltd., Korea]
RIS-KOR-1083 [Janssen Korea, Ltd., Korea]
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Completed
Study Start: August 2009
Primary Completion: August 2009 [Actual]
Study Completion: August 2009 [Actual]
First Submitted: December 10, 2013
First Submitted that
Met QC Criteria:
December 10, 2013
First Posted: December 16, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 10, 2013
Last Update Posted: December 16, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Korea, Ltd., Korea
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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.
Open or close this module Conditions
Conditions: Healthy
Keywords: Healthy
Risperdal OD
Risperdal Quicklet
Korea
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 36 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Plasma concentrations of Risperidone
[ Time Frame: Up to 24 hours postdose ]

Secondary Outcome Measures:
1. Number of participants with adverse events as a measure of safety
[ Time Frame: Approximately 10 days ]

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Study Officials: Janssen Korea, Ltd., Korea Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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