Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Study Overview
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Brief Summary
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This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.

Official Title
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A Randomized, Open-label Study to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: DWP14012
* Drug: Aspirin


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. For women, negative urine pregnancy test (hCG) at the screening visit Exclusion Criteria: Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, salicylic acid, or other drugs (non-steroidal anti-inflammatory drug [NSAIDs], antibiotics, etc.) Women who are or may be pregnant, or are breast-feeding Subjects with a history related to blood clotting disorder or bleeding Subjects with a medical diagnosis of functional constipation 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 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, and disagreed to refrain from donating sperms during this period Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Aspirin (substrate), DWP14012 (Perpetrator) | Drug: DWP14012<br>* Potassium-competitive acid blocker<br>Drug: Aspirin<br>* acetylsalicylic acid<br>|
| Experimental: Cohort 2<br>DWP14012 (substrate), Aspirin (Perpetrator) | Drug: DWP14012<br>* Potassium-competitive acid blocker<br>Drug: Aspirin<br>* acetylsalicylic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of aspirin |  | Up to 21 days | 
| Cmax,ss of DWP14012 |  | Up to 13 days | 
| Emax |  | Up to 21 days | 
| AUClast of aspirin |  | Up to 21 days | 
| AUCτ,ss of DWP14012 |  | Up to 13 days | 
| time to Emax |  | Up to 21 days | 
| AUEC |  | Up to 21 days |