Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

This study has been completed.
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01094847
First received: March 26, 2010
Last updated: May 19, 2011
Last verified: May 2011

March 26, 2010
May 19, 2011
April 2010
May 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of Mosapride [ Time Frame: 48hr after 1st administration ] [ Designated as safety issue: No ]
AUC(0-last), Cmax
Same as current
Complete list of historical versions of study NCT01094847 on ClinicalTrials.gov Archive Site
Pharmacokinetics of mosapride, M-1 [ Time Frame: 48hr after 1st administration ] [ Designated as safety issue: No ]
  • AUCoo, tmax, t 1/2, CL/F, Vd/F of Mosapride
  • AUC(0-last), AUCoo, Cmax, tmax, t 1/2 of M-1
Same as current
Not Provided
Not Provided
 
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Bioequivalence
Drug: DWJ1252
tablet(oral) administration following the schedule of each arm
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
May 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01094847
DW_J1252001P
Not Provided
Somin Bae, Daewoong Pharmaceutical Co. LTD
Daewoong Pharmaceutical Co. LTD.
Not Provided
Principal Investigator: Kyung-Sang Yu Seoul National University Hospital IRB
Daewoong Pharmaceutical Co. LTD.
May 2011

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