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
| Registry | NCT05574374 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 36 (Actual) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (Industry) |
| Conditions | Drug Drug Interaction |
| Interventions | DWP14012, DWC202202, DWC202203 (Drug) |
| Dates | start 2022-09-21, primary completion 2023-03-06, completion 2023-03-06, first posted 2022-10-10, last updated 2023-04-04 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Drug Drug Interaction All trials of DWP14012 All trials of DWC202202
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 | Experimental | Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 | * 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 |
| Cohort 2 | Experimental | Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 | * 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 |
| Cohort 3 | Experimental | Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 | * 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 |
Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |