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This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other |
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| Group 2 | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-383(Fed) | Drug | After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2) | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2) | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
1 administration)
Other exclusive criteria, as defined in the protocol
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jisoo Kim, PL | Contact | 02-6373-0785 | jisoo.kim@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Jaeyong chung, PI | Seoul National University Bundang Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| CKD-383(Fasted) | Drug | After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day. |
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| D004700 | Endocrine System Diseases |