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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Risperdal OD Tab. 2mg Drug: Risperdal Quicklet Tab. 2mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea
Study Start Date : August 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

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.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012049


Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT02012049    
Other Study ID Numbers: CR016576
RISSCH1015 ( Other Identifier: Janssen Korea, Ltd., Korea )
RIS-KOR-1083 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013
Keywords provided by Janssen Korea, Ltd., Korea:
Healthy
Risperdal OD
Risperdal Quicklet
Korea
Additional relevant MeSH terms:
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Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents