Healthy Volunteer, Renal Impairments
Conditions
Brief summary
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.
Interventions
DRUGYHD1119 75mg
A single oral dose
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 19\ 75 years old, healthy volunteers and renal impairments * eGFR \>= 60mL/min/1.73m2 * 60 mL/min/1.73m2 \> eGFR \>= 30mL/min/1.73m2 * written informed consent
Exclusion criteria
* AST or ALT \> 1.5 \* Upper normal range * Total bilirubin \> 1.5 \* Upper normal range * Blood CPK \> 1.5 \* Upper normal range * Total Cholesterol \>1.5 \* Upper normal range * Woman who is pregnant or lactating * Patients who are difficult to participate in cinical trials judged by Investigators * have participated in other clinical trials within 180 days before IP intake
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 | 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour |
| AUCinf | 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 |
| CL/F | 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 |
Countries
South Korea
Outcome results
None listed