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 19 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 Identifier	NCT04490434
Sponsor	Daewoong Pharmaceutical Co. LTD.
Last Modified on	19 February 2024

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