Skip to main content
OpenTrials
Completed

NCT Number: NCT01094847

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bioequivalence

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWJ1252

Drug

tablet(oral) administration following the schedule of each arm

Primary outcomes

  1. Pharmacokinetics of Mosapride

    Time frame: 48hr after 1st administration

    AUC(0-last), Cmax

Secondary outcomes

  1. Pharmacokinetics of mosapride, M-1

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Mar 29, 2010
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.