Drug-drug Interaction
Conditions
Brief summary
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy
Interventions
DRUGDWC202211 100mg
DWC202211 for 5 days Aspirin 100mg
DRUGDWC202212 5mg
DWC202212 for 3 days Rabeprazole 5mg
DRUGDWC202211 100mg + DWC202212 5mg
DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | up to 27 days |
| AUClast | up to 27 days |
Secondary
| Measure | Time frame |
|---|---|
| DWC202211 Cmin,ss | up to 27 days |
| DWC202211 Cavg,ss | up to 27 days |
| DWC202211 CLss/F | up to 27 days |
| DWC202211 Vdss/f | up to 27 days |
| DWC202211 PTF | up to 27 days |
| DWC202212 Tmax,ss | up to 27 days |
| DWC202211 Tmax,ss | up to 27 days |
| DWC202212 Cmin,ss | up to 27 days |
| DWC202212 Cavg,ss | up to 27 days |
| DWC202212 CLss/F | up to 27 days |
| DWC202212 Vdss/f | up to 27 days |
| DWC202212 PTF | up to 27 days |
| DWC202212 T1/2,ss | up to 27 days |
| DWC202211 T1/2,ss | up to 27 days |
Countries
South Korea
Outcome results
None listed