Status:
UNKNOWN
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
Detailed Description
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04490434
Start Date
June 19 2020
End Date
November 30 2020
Last Update
July 29 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080