Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
NCT ID: NCT01094847
Last Updated: 2011-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Treatment A
DWJ1252 given by oral administration under fasting conditions
DWJ1252
tablet(oral) administration following the schedule of each arm
Treatment B
DWJ1252 given by oral administration, 30 minutes after a meal
DWJ1252
tablet(oral) administration following the schedule of each arm
Treatment C
mosapride by oral administration 30 minutes before meals
No interventions assigned to this group
Interventions
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DWJ1252
tablet(oral) administration following the schedule of each arm
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
50 Years
MALE
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Daewoong Pharmaceutical Co. LTD
Principal Investigators
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Kyung-Sang Yu
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital IRB
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DW_J1252001P
Identifier Type: -
Identifier Source: org_study_id
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