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

Study Overview
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Brief Summary
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drug-drug interaction between DWP14012 and three different kinds of NSAIDs

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

Official Title
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A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: DWP14012
* Drug: Celecoxib
* Drug: Naproxen
* Drug: Meloxicam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1, A (DWP14012/Celecoxib)<br>Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Celecoxib<br>* Celecoxib 200mg, bid<br>|
| Experimental: Cohort 1, B (DWP14012/Celecoxib)<br>Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Celecoxib<br>* Celecoxib 200mg, bid<br>|
| Experimental: Cohort 2, C (DWP14012/Naproxen)<br>Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Naproxen<br>* Naproxen 500mg, bid<br>|
| Experimental: Cohort 2, D (DWP14012/Naproxen)<br>Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Naproxen<br>* Naproxen 500mg, bid<br>|
| Experimental: Cohort 3, E (DWP14012/Meloxicam)<br>Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Meloxicam<br>* Meloxicam 15mg, qd<br>|
| Experimental: Cohort 3, F (DWP14012/Meloxicam)<br>Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. | Drug: DWP14012<br>* DWP14012 40mg, bid<br>Drug: Meloxicam<br>* Meloxicam 15mg, qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm A, Cmax,ss of Celecoxib | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm A, AUCτ,ss of Celecoxib | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm B, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm B, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm C, Cmax,ss of Naproxen | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm C, AUCτ,ss of Naproxen | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm D, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm D, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 11,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm E, Cmax,ss of Meloxicam | Maximum measured plasma concentration at steady-state | Day 7,(0 hours (pre-dose), 1 72 hours) / Day 16,(0 hours (pre-dose), 1 72 hours) | 
| Arm E, AUCτ,ss of Meloxicam | Area under the plasma concentration-time curve | Day 7,(0 hours (pre-dose), 1 72 hours) / Day 16,(0 hours (pre-dose), 1 72 hours) | 
| Arm D, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 13,(0 hours (pre-dose), 0.5 48 hours) | 
| Arm D, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5 48 hours) / Day 13,(0 hours (pre-dose), 0.5 48 hours) |