Healthy Male Volunteers
Conditions
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
Interventions
DRUGDWP14012
DWP14012 40mg, bid
DRUGCelecoxib
Celecoxib 200mg, bid
DRUGNaproxen
Naproxen 500mg, bid
DRUGMeloxicam
Meloxicam 15mg, qd
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm A, Cmax,ss of Celecoxib | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Maximum measured plasma concentration at steady-state |
| Arm A, AUCτ,ss of Celecoxib | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Area under the plasma concentration-time curve |
| Arm B, Cmax,ss of DWP14012 | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Maximum measured plasma concentration at steady-state |
| Arm B, AUCτ,ss of DWP14012 | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Area under the plasma concentration-time curve |
| Arm C, Cmax,ss of Naproxen | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Maximum measured plasma concentration at steady-state |
| Arm C, AUCτ,ss of Naproxen | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Area under the plasma concentration-time curve |
| Arm D, Cmax,ss of DWP14012 | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Maximum measured plasma concentration at steady-state |
| Arm D, AUCτ,ss of DWP14012 | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) | Area under the plasma concentration-time curve |
| Arm E, Cmax,ss of Meloxicam | Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours) | Maximum measured plasma concentration at steady-state |
| Arm E, AUCτ,ss of Meloxicam | Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours) | Area under the plasma concentration-time curve |
Countries
South Korea
Contacts
Primary ContactJang In-Jin, MD, PhD
Outcome results
None listed