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Bioequivalence Test for Risperdal 2mg of Janssen Korea

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ClinicalTrials.gov Identifier: NCT02012049
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date  ICMJE December 10, 2013
First Posted Date  ICMJE December 16, 2013
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
Plasma concentrations of Risperidone [ Time Frame: Up to 24 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
Number of participants with adverse events as a measure of safety [ Time Frame: Approximately 10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Test for Risperdal 2mg of Janssen Korea
Official Title  ICMJE Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Risperdal OD / Risperdal Quicklet
    Risperdal OD (investigational drug) + Risperdal Quicklet (control drug)
    Interventions:
    • Drug: Risperdal OD Tab. 2mg
    • Drug: Risperdal Quicklet Tab. 2mg
  • Experimental: Risperdal Quicklet / Risperdal OD
    Risperdal Quicklet (control drug) + Risperdal OD (investigational drug)
    Interventions:
    • Drug: Risperdal OD Tab. 2mg
    • Drug: Risperdal Quicklet Tab. 2mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2013)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012049
Other Study ID Numbers  ICMJE CR016576
RISSCH1015 ( Other Identifier: Janssen Korea, Ltd., Korea )
RIS-KOR-1083 ( Other Identifier: Janssen Korea, Ltd., Korea )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Janssen Korea, Ltd., Korea
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Korea, Ltd., Korea
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
PRS Account Janssen Korea, Ltd., Korea
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP