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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End Stage Renal Disease(ESRD) | Experimental | CKD-501 will be administered to patients who have required dialysis and non-dialysis eGFR(estimate glomerular filtration rate ) is Less than 15. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress |
|
| normal renal function | Active Comparator | CKD-501 will be administered to normal renal function subject who have eGFR(estimate glomerular filtration rate ) of 90 or more. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress |
|
| Mild renal impairment | Experimental | CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 | Drug | From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered . |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects |
| 0-48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects |
| 0-48 hrs |
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Inclusion Criteria
All subjects:
Normal Renal Function subjects:
Renally impaired subjects:
Exclusion Criteria
All subjects:
Normal Renal Function subjects:
Renally impaired subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Kuk Shin, Ph.D. M.D | The Inje University Busan Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Inje University Busan Paik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
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|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |