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Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094847
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date May 20, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
Pharmacokinetics of Mosapride [ Time Frame: 48hr after 1st administration ]
AUC(0-last), Cmax
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
Pharmacokinetics of mosapride, M-1 [ Time Frame: 48hr after 1st administration ]
  • AUCoo, tmax, t 1/2, CL/F, Vd/F of Mosapride
  • AUC(0-last), AUCoo, Cmax, tmax, t 1/2 of M-1
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 Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Official Title  ICMJE Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Brief Summary The purpose of this study is to compare and explore bioavailability of mosapride, the main component of DWJ1252(Test drug) and mosapride medicine(Reference drug).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Bioequivalence
Intervention  ICMJE Drug: DWJ1252
tablet(oral) administration following the schedule of each arm
Study Arms  ICMJE
  • Experimental: Treatment A
    DWJ1252 given by oral administration under fasting conditions
    Intervention: Drug: DWJ1252
  • Active Comparator: Treatment B
    DWJ1252 given by oral administration, 30 minutes after a meal
    Intervention: Drug: DWJ1252
  • No Intervention: Treatment C
    mosapride by oral administration 30 minutes before meals
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
Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • a healthy adult male within the range of 20 to 50 years old at the time of screening
  • with weight of more than 55kg, in the range of IBW 20%: IBW(kg)={height(cm)-100}*0.9
  • who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion Criteria:

  • one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
  • one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
  • one with genetic disease like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • one who is allergic or has clinically significant allergic history to the component of the investigational drug (mosaprisde), and any component from same family, or to other drugs(Aspirin, antibiotics, etc)
  • one who shows different rhythm than sinus rhythm in screening, like QTc >450ms on electrocardiogram, PR interval>200msec or QRS interval 120>msec
  • one who shows the following result in clinical laboratory test: AST,ALT>1.25 times of the upper limit of normal range
  • one who shows vital signs with the number of systolic blood pressure of 160 mmHg or 100 mmHg, and the number of diastolic blood pressure of 95mmHg or 60mmHg
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094847
Other Study ID Numbers  ICMJE DW_J1252001P
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Somin Bae, Daewoong Pharmaceutical Co. LTD
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung-Sang Yu Seoul National University Hospital IRB
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date May 2011

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