Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

NCT01094847 | Completed Phase 1

• 1 other identifier: DW_J1252001P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of Mosapride

  AUC(0-last), Cmax

  48hr after 1st administration

Secondary Outcomes (1)

• Pharmacokinetics of mosapride, M-1

  48hr after 1st administration

Study Arms (3)

Treatment A

EXPERIMENTAL

DWJ1252 given by oral administration under fasting conditions

Drug: DWJ1252

Treatment B

ACTIVE COMPARATOR

DWJ1252 given by oral administration, 30 minutes after a meal

Drug: DWJ1252

Treatment C

NO INTERVENTION

mosapride by oral administration 30 minutes before meals

Interventions

DWJ1252 DRUG

tablet(oral) administration following the schedule of each arm

Treatment A; Treatment B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Kyung-Sang Yu

  Seoul National University Hospital IRB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 29, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Last Updated: May 20, 2011

Record last verified: 2011-05

Locations

KR (1)