A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg (DWCZP-I-1)

This study has been completed.
Sponsor:
Collaborators:
The Catholic University of Korea
Konkuk University Hospital
Naju National Hospital
Seoul National Hospital
Wonkwang University
DongGuk University
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01654601
First received: July 25, 2012
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Schizophrenia
Interventions: Drug: DWCZP
Drug: Clozaril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from a specialty clinic at s hospital, in Seoul, Naju, Chungju, Iksan and Kyungju, Korea between June 2012 and March 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
32 participantsrecruited : 28 screened, 4 excluded(3 did not meet inclusion criteria and 1 refused participation)

Reporting Groups
  Description
A Group DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
B Group Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)

Participant Flow for 2 periods

Period 1:   1st Administration
    A Group     B Group  
STARTED     14     14  
COMPLETED     12     12  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 0  
Protocol Violation                 0                 2  

Period 2:   2nd Administration
    A Group     B Group  
STARTED     12     12  
COMPLETED     11     11  
NOT COMPLETED     1     1  
Adverse Event                 1                 0  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A Group DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
B Group Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
Total Total of all reporting groups

Baseline Measures
    A Group     B Group     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     14     28  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     8     6     14  
Male     6     8     14  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     14     14     28  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     14     14     28  



  Outcome Measures
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1.  Primary:   Maximum Concentration of Clozapine in Plasma   [ Time Frame: Up to 12hours ]

2.  Secondary:   Time to Reach Maximum Concentration of Clozapine in Plasma   [ Time Frame: Up to 12hours ]

3.  Secondary:   Terminal Half Life of Clozapine in Plasma   [ Time Frame: Up to 12hours ]

4.  Secondary:   Accumulation Rate of Clozapine in Plasma   [ Time Frame: Up tp 12hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Won-myung Bahk. M.D. PhD.
Organization: The Catholic university of Korea
phone: 82-2-3779-1051
e-mail: wmbahk@catholic.ac.kr


No publications provided


Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01654601     History of Changes
Other Study ID Numbers: DWCZP-I-1
Study First Received: July 25, 2012
Results First Received: December 17, 2013
Last Updated: February 13, 2014
Health Authority: Korea: Food and Drug Administration