Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

Study Overview
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Brief Summary
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A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects

Official Title
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A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: DWP14012
* Drug: DWC202202
* Drug: DWC202203


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged ≥ 19 and ≤ 50 years at screening Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening ※ BMI (kg/m2) = body weight (kg)/[height (m)]2 Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc. Exclusion Criteria: Subjects with a history related to blood clotting disorder or bleeding Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc. Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc. Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration Subjects who are smoking

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

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Treatment A: DWC202202 1 tablet qd for 7days Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days | Drug: DWP14012<br>* Potassium-competitive acid blocker<br>Drug: DWC202202<br>* Clopidogrel Bisulfate<br>Drug: DWC202203<br>* Proton pump inhibitor<br>|
| Experimental: Cohort 2<br>Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days Treatment A: DWC202202 1 tablet qd for 7days Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days | Drug: DWP14012<br>* Potassium-competitive acid blocker<br>Drug: DWC202202<br>* Clopidogrel Bisulfate<br>Drug: DWC202203<br>* Proton pump inhibitor<br>|
| Experimental: Cohort 3<br>Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days Treatment A: DWC202202 1 tablet qd for 7days | Drug: DWP14012<br>* Potassium-competitive acid blocker<br>Drug: DWC202202<br>* Clopidogrel Bisulfate<br>Drug: DWC202203<br>* Proton pump inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emax |  | up to 50 days | 
| AUEC0-24 |  | up to 50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DWC202202 Cmax,ss |  | up to 50 days | 
| DWC202202 active metabolite Cmax,ss |  | up to 50 days | 
| DWC202202 AUCtau,ss |  | up to 50 days | 
| DWC202202 active metabolite AUCtau,ss |  | up to 50 days | 
| DWC202202 AUCinf,ss |  | up to 50 days | 
| DWC202202 active metabolite AUCinf,ss |  | up to 50 days | 
| DWC202202 Tmax,ss |  | up to 50 days | 
| DWC202202 active metabolite Tmax,ss |  | up to 50 days | 
| DWC202202 t1/2,ss |  | up to 50 days | 
| DWC202202 active metabolite t1/2,ss |  | up to 50 days | 
| DWC202202 Cmin,ss |  | up to 50 days | 
| DWC202202 active metabolite Cmin,ss |  | up to 50 days | 
| DWC202202 Cavg,ss |  | up to 50 days | 
| DWC202202 active metabolite Cavg,ss |  | up to 50 days | 
| DWC202202 CLss/F |  | up to 50 days | 
| DWC202202 Vd,ss/F |  | up to 50 days | 
| DWC202202 PTF (peak to trough fluctuation) |  | up to 50 days | 
| DWC202202 active metabolite PTF (peak to trough fluctuation) |  | up to 50 days | 
| DWC202202 R |  | up to 50 days | 
| DWC202202 active metabolite MR |  | up to 50 days |