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).

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: DWJ1252

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment A; DWJ1252 given by oral administration under fasting conditions	Drug: DWJ1252; tablet(oral) administration following the schedule of each arm
ACTIVE_COMPARATOR: Treatment B; DWJ1252 given by oral administration, 30 minutes after a meal	Drug: DWJ1252; tablet(oral) administration following the schedule of each arm
NO_INTERVENTION: Treatment C; mosapride by oral administration 30 minutes before meals

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Kyung-Sang Yu, Seoul National University Hospital IRB

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: March 26, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (ESTIMATE): March 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2011
• Last Update Submitted That Met QC Criteria: May 19, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: DW_J1252001P