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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Single-dose of CKD-510 will be administered as oral capsule in a fasted state.
Single-dose of CKD-510 will be administered as oral tablet in a fasted state.
Single-dose of CKD-510 will be administered as oral tablet in a fed state.
Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Plasma Cmax after administration of either capsule or tablet formulation in fasted state
Maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From Day 1 to Day 3 of each Treatment Period
Plasma T1/2 after administration of tablet formulation in the fed and fasted states
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Terminal phase elimination half-life (T1/2)
Time frame: From Day 1 to Day 3 of each Treatment Period
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
Time frame: From Day 1 to Day 7