Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

  • STATUS
    Recruiting
  • participants needed
    110
  • sponsor
    Daewoong Pharmaceutical Co. LTD.
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Updated on 16 February 2024
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NSAID
steroidal anti-inflammatory drugs
drug-drug interaction

Summary

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

Description

to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers

Details
Condition Healthy Male Volunteers
Age 19years - 50years
Treatment Meloxicam, DWP14012, Celecoxib, Naproxen
Clinical Study IdentifierNCT04490434
SponsorDaewoong Pharmaceutical Co. LTD.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening
Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit

Exclusion Criteria

Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
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