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
The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.
Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-1705 | Experimental | Tablet formulation for oral administration, single dose of NVP-1705 at Day 1 |
|
| NVP-1705-R | Active Comparator | Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1705 | Drug | NVP-1705 |
| |
| NVP-1705-R |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Area under the plasma drug concentration-time curve(AUCt) | Pharmacokinetics parameter derived from plasma | 0 ~ 48 hours |
| Evaluation of Maximum observed plasma concentration(Cmax) | Pharmacokinetics parameter derived from plasma | 0 ~ 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Pharmacokinetics parameter derived from plasma | 0 ~ 48 hours |
| Evaluation of AUCt/AUC∞ | Pharmacokinetics parameter derived from plasma |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jae Woo Kim, M.D., Ph.D | H+ Yangji hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | Nambusunhwan-ro | 08779 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single-dose, crossover study
Not provided
Not provided
Not provided
Not provided
| Drug |
NVP-1705-R |
|
| 0 ~ 48 hours |
| Evaluation of Time of peak concentration(Tmax) | Pharmacokinetics parameter derived from plasma | 0 ~ 48 hours |
| Evaluation of Terminal phase of Half-life(t1/2) | Pharmacokinetics parameter derived from plasma | 0 ~ 48 hours |