Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 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
Potassium-competitive acid blocker
Drug: DWC202202
Clopidogrel Bisulfate
Drug: DWC202203
Proton pump inhibitor
|
| Experimental: Cohort 2 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
Potassium-competitive acid blocker
Drug: DWC202202
Clopidogrel Bisulfate
Drug: DWC202203
Proton pump inhibitor
|
| Experimental: Cohort 3 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
Potassium-competitive acid blocker
Drug: DWC202202
Clopidogrel Bisulfate
Drug: DWC202203
Proton pump inhibitor
|
Outcome Measures
Primary Outcome Measures
- Emax [up to 50 days]
- AUEC0-24 [up to 50 days]
Secondary Outcome Measures
- 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]
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.
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012110