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Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

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ClinicalTrials.gov Identifier: NCT01094847
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.

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).

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: DWJ1252 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Study Start Date : April 2010
Actual Primary Completion Date : May 2010

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



Primary Outcome Measures :
  1. Pharmacokinetics of Mosapride [ Time Frame: 48hr after 1st administration ]
    AUC(0-last), Cmax


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094847


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
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Principal Investigator: Kyung-Sang Yu Seoul National University Hospital IRB

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Responsible Party: Somin Bae, Daewoong Pharmaceutical Co. LTD
ClinicalTrials.gov Identifier: NCT01094847     History of Changes
Other Study ID Numbers: DW_J1252001P
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
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Mosapride
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs