Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

Study Overview
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Brief Summary
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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).

Official Title
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Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: DWJ1252


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>DWJ1252 given by oral administration under fasting conditions | Drug: DWJ1252<br>* tablet(oral) administration following the schedule of each arm<br>|
| Active Comparator: Treatment B<br>DWJ1252 given by oral administration, 30 minutes after a meal | Drug: DWJ1252<br>* tablet(oral) administration following the schedule of each arm<br>|
| No Intervention: Treatment C<br>mosapride by oral administration 30 minutes before meals | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Mosapride | AUC(0-last), Cmax | 48hr after 1st administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of mosapride, M-1 | AUCoo, tmax, t 1/2, CL/F, Vd/F of Mosapride AUC(0-last), AUCoo, Cmax, tmax, t 1/2 of M-1 | 48hr after 1st administration |