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The purpose of this study is to evaluate the pharmacokinetics and safety of CKD-396.
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-396 and Co-administration of CKD-501 and D759 in Healthy Adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 and D759 | Drug | Reference drug, CKD-501 1T and D759 1T, QD, PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CKD-501, D759 and CKD-396 | Maximum plasma concentration of CKD-501, D759 and CKD-396 | 0(predose)~48 hours |
| AUClast of CKD-501, D759 and CKD-396 | Area under the plasma concentration-time curve to last concentration of CKD-501, D759 and CKD-396 | 0(predose)~48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
Subjects who have diabetic ketoacidoisis, diabetic coma, diabetic precoma, Type 1 diabetes
Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product(lobeglitazone, sitagliptin) and same class drug with thiazolidinediones
Subjects who have severe infectious disease and severe trauma before and after operation
Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
Pregnant or lactating women
Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons
Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
Subjects who received a blood transfusion within 60 days before the first dose of the investigational product
Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Soo Park, Ph.D. M.D | Contact | +82-2-2228-0401 | minspark@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park, Ph.D. M.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Soeul | South Korea |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
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| CKD-396 |
| Drug |
Reference drug, CKD-396 1T, QD, PO |
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