Bioequivalence
Conditions
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).
Interventions
DRUGDWJ1252
tablet(oral) administration following the schedule of each arm
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Mosapride | 48hr after 1st administration | AUC(0-last), Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of mosapride, M-1 | 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 |
Countries
South Korea
Outcome results
None listed