Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

Daewoong Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: DWJ1252

Study type

Interventional

Funder types

Industry

Identifiers

NCT01094847

DW_J1252001P

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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