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 trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YHD1119 75mg, 150mg NF | Experimental | CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF |
|
| YHD1119 75mg | Experimental | 60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHD1119 75mg | Drug | A single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | |
| AUClast | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | |
| Tmax | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | |
| t1/2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SeungHoon Han | The Catholic University of Korea | Principal Investigator |
| Hyounggyoon Yoo | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Gyeonggi-do | South Korea | ||||
| The Catholic University of Korea, Seoul St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38197000 | Derived | Park M, Choi S, Han S, Shin W, Kim A, Han S, Kim B, Lim Y, Yoo H. Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. Transl Clin Pharmacol. 2023 Dec;31(4):226-237. doi: 10.12793/tcp.2023.31.e20. Epub 2023 Dec 20. |
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
| 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour |
| CL/F | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour |
| V/F | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour |
| Seoul |
| South Korea |