Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

Bioequivalence Clinical Trial

Official title:

Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094847
• Other study ID #: DW_J1252001P
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2010
• Last updated: May 19, 2011
• Start date: April 2010

Study information

• Verified date: May 2011
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• DWJ1252
tablet(oral) administration following the schedule of each arm

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Mosapride	AUC(0-last), Cmax	48hr after 1st administration	No
Secondary	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	No