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The purpose of this study is to determine the relative bioavailability of CKD-510 tablet formulation compared with CKD-510 capsule formulation, and to characterize the effect of food on the CKD-510 tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects will receive single-dose of CKD-510 capsule in fasted state (treatment A) on Day 1 of Period 1 and tablet in fasted state (treatment B) on Day 1 of Period 2, and then receive tablet in a fed state (treatment C) on Day 1 of Period 3. A washout period will be at least 7 days between each treatment period. |
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| Group 2 | Experimental | Subjects will receive single-dose of CKD-510 tablet in a fed state (treatment C) on Day 1 of Period 1 and tablet in fasted state (treatment B) on Day 1 of Period 2, and then receive capsule in fasted state (treatment A) on Day 1 of Period 3. A washout period will be at least 7 days between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-510 capsule (reference) | Drug | Single-dose of CKD-510 will be administered as oral capsule in a fasted state. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cmax after administration of either capsule or tablet formulation in fasted state | Maximum plasma concentration (Cmax) | From Day 1 to Day 3 of each Treatment Period |
| Plasma AUC after administration of either capsule or tablet formulation in fasted state | Area under the concentration-time curve (AUC) | From Day 1 to Day 3 of each Treatment Period |
| Plasma Tmax after administration of either capsule or tablet formulation in fasted state | Time to maximum plasma concentration (Tmax) | From Day 1 to Day 3 of each Treatment Period |
| Plasma T1/2 after administration of either capsule or tablet formulation in fasted state: T1/2 | Terminal phase elimination half-life (T1/2) | From Day 1 to Day 3 of each Treatment Period |
| Plasma Cmax after administration of tablet formulation in the fed and fasted states | Maximum plasma concentration (Cmax) | From Day 1 to Day 3 of each Treatment Period |
| Plasma AUC after administration of tablet formulation in the fed and fasted states | Area under the concentration-time curve (AUC) | From Day 1 to Day 3 of each Treatment Period |
| Plasma Tmax after administration of tablet formulation in the fed and fasted states | Time to maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
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| CKD-510 tablet (test) | Drug | Single-dose of CKD-510 will be administered as oral tablet in a fasted state. |
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| CKD-510 tablet (test) | Drug | Single-dose of CKD-510 will be administered as oral tablet in a fed state. |
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| From Day 1 to Day 3 of each Treatment Period |
| Plasma T1/2 after administration of tablet formulation in the fed and fasted states | Terminal phase elimination half-life (T1/2) | From Day 1 to Day 3 of each Treatment Period |
| Safety and tolerability including treatment-emergent AE and treatment-emergent SAE | From Day 1 to Day 7 |