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 objective of this open-label, randomized, 2*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
Healthy volunteers are administrated single-dose over the period I and II (crossover) of CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CG1801 | Experimental | Dosing 'CG1801' followed by dosing 'CGL1802' |
|
| CGL 1802 | Experimental | Dosing 'CGL1802' followed by dosing 'CG1801' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG1801 | Drug | Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib | Area Under Curve [AUC]last of CGL1802 will be evaluated | Day1 pre-dose and each of the post-doses of each of the 2 treatment periods in CG1801 and CGL1802 Group. |
| Maximum Plasma Concentration [Cmax] of polmacoxib | Maximum Plasma Concentration [Cmax] of CGL1802 will be evaluated | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve [AUC]last of polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. | |
| Maximum Plasma Concentration [Cmax] of polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CGL1802 | Drug | Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2 |
|
| AUCinf of polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
| Time to maximum plasma concentration [Tmax] of polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
| t1/2 of polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
| clearance [CL/F] of Polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |
| Volume of distribution [Vd/F] of Polmacoxib | Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group. |