Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Aspirin (substrate), DWP14012 (Perpetrator) |
Drug: DWP14012
Potassium-competitive acid blocker
Drug: Aspirin
acetylsalicylic acid
|
| Experimental: Cohort 2 DWP14012 (substrate), Aspirin (Perpetrator) |
Drug: DWP14012
Potassium-competitive acid blocker
Drug: Aspirin
acetylsalicylic acid
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012108