Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple Ascending Dose of DW4421, phase I
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 (DW4421S 5mg) | Experimental | DW4421S-T0, 1 tablet will be orally administered in BID for 7days |
|
| cohort 2 (DW4421S 10mg) | Experimental | DW4421S-T0, 1 tablet will be orally administered in QD for 7days |
|
| cohort 3 (DW4421S 15mg) | Experimental | DW4421S-T2, 1 tablet will be orally administered in QD for 7days |
|
| cohort 4 (DW4421S 20mg) | Experimental | DW4421S-T1, 1 tablet will be orally administered in QD for 7days |
|
| cohort 5 (DW4421S 30mg) | Experimental | DW4421S-T3, 1 tablet will be orally administered in QD for 7days |
|
| cohort 6 (DW4421S 40mg) | Experimental | DW4421S, 1 tablet will be orally administered in QD for 7days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW4421S-T0 | Drug | DW4421 5mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration | Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration | Day 7 |
| Cmax of DW4421 following multiple oral administration | Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration | Day 7 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | South Korea |
A decision on whether to share individual participant data has not yet been made. We plan to evaluate the feasibility of data sharing after the study is completed and the primary results are published
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| cohort 7 (Zastaprazan 20mg) | Active Comparator | DW4421-3, 1 tablet will be orally administered in QD for 7days |
|
| DW4421S-T2 |
| Drug |
DW4421 15mg |
|
| DW4421S-T1 | Drug | DW4421 20mg |
|
| DW4421S-T3 | Drug | DW4421 30mg |
|
| DW4421S | Drug | DW4421 40mg |
|
| DW4421-3 | Drug | Zastaprazan 20mg |
|