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This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: DWP16001 Drug A | Experimental | 1 tablet, Oral, once daily single dose |
|
| Intervention: DWP16001 Drug C | Experimental | 1 tablet, Oral, once daily single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 Drug A | Drug | DWP16001 Drug A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss of DWP16001 | Peak Plasma Concetration of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |
| AUClast of DWP16001 | The area under the plasma drug concentration-time curve of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of DWP16001 | Time at Cmax of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |
| T1/2 of DWP16001 | Half life of DWP16001 |
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Inclusion Criteria:
- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA unuversity bundang medical center | Seongnam | South Korea |
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| DWP16001 Drug C |
| Drug |
DWP16001 Drug C |
|
| At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |
| CL/F of DWP16001 | Apparent total clearance of the drug from plasma after oral administration of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |
| Vd/F of DWP16001 | Volume of distribution of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |