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
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A: RTRT | Experimental | T: DWJ1589 R: DWC202315 |
|
| Sequence B: TRTR | Experimental | T: DWJ1589 R: DWC202315 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 | Drug | DWJ1589 or DWC202315 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum serum concentration(Cmax) of DWJ1589 and DWC202315 | Cmax of DWJ1589 and DWC202315 | At pre-dose (0 hour), and post-dose 0.83 to 72 hour. |
| The Area under the curve(AUC)last of DWJ1589 and DWC202315 | AUClast of DWJ1589 and DWC202315 | At pre-dose (0 hour), and post-dose 0.83 to 72 hour. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHIN, CPL | Contact | 02-550-8858 |
| Name | Affiliation | Role |
|---|---|---|
| KANG, MD, PhD | H Plus Yangji Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Period 2 |
| Drug |
DWJ1589 or DWC202315 |
|
| Period 3 | Drug | DWJ1589 or DWC202315 |
|
| Period 4 | Drug | DWJ1589 or DWC202315 |
|