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To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride | Experimental | This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. |
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| CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride | Experimental | This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet | Drug | From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects | Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period | 0-24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501 | Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period | 0-24 hrs |
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Inclusion Criteria:
Exclusion Criteria:
Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
Inadequate laboratory test result
Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
Previously participated in other trial within 60 days
Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
Subject has taken abnormal meals which affects the ADME of drug
Impossible to taking the institutional standard meal
Previously donate whole blood within 60 days or component blood within 20 days
Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
An impossible one who participates in clinical trial by investigator's decision including laboratory test result
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Park, Ph.D. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Korea University Anam Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
| D013607 | Tablets |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| CKD-501 placebo tablet, Glimepiride 4 mg tablet | Drug | From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2. |
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