The purpose of this study is to assess between the renal impaired patients and normal renal function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of instructions.
A Phase 1, Non-randomized, Open, Parallel-Group Clinical trial
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .
The Inje University Busan Paik Hospital
Busan, South Korea
The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects
* Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)36hr (Day3)48hr- total 12 timepoints per period * Additional Blood sampling for unbound fraction analysis : (Day 1) 1hr, 6hr, 12hr * Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr
Time frame: 0-48 hrs
The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects
* Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)12hr (Day3)0hr- total 12 timepoints per period * Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr
Time frame: 0-48 hrs
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