Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGCKD-510 capsule (reference)
Single-dose of CKD-510 will be administered as oral capsule in a fasted state.
DRUGCKD-510 tablet (test)
Single-dose of CKD-510 will be administered as oral tablet in a fasted state.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male or female subject between 18 and 60 years of age * In generally good health, based upon medical/surgical history and the results of physical examination, vital signs, safety laboratory assessments, and 12-lead ECG * Body mass index (BMI) between 18 and 32 kg/m2 * If a female subject of childbearing potential, agrees to use a highly effective method of contraception during study participation and for 90 days after the last administration of study drug. * If a male subject with a female partner of childbearing potential, is surgically sterile or agrees to use a highly effective method of contraception during study participation and for 90 days after the last administration of study drug * Negative test result for SARS-CoV-2
Exclusion criteria
* Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, or allergic disease or any other condition * Any hypersensitivity or allergy to CKD-510 or its excipients or to any medicinal products with similar chemical structures * History of malignancy, other than successfully treated basal cell or squamous cell skin cancer * History or presence of an abnormal 12-lead ECG * Acute illness considered clinically significant by the Investigator within 30 days prior to Randomization * Any other investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Cmax after administration of either capsule or tablet formulation in fasted state | From Day 1 to Day 3 of each Treatment Period | Maximum plasma concentration (Cmax) |
| Plasma AUC after administration of either capsule or tablet formulation in fasted state | From Day 1 to Day 3 of each Treatment Period | Area under the concentration-time curve (AUC) |
| Plasma Tmax after administration of either capsule or tablet formulation in fasted state | From Day 1 to Day 3 of each Treatment Period | Time to maximum plasma concentration (Tmax) |
| Plasma T1/2 after administration of either capsule or tablet formulation in fasted state: T1/2 | From Day 1 to Day 3 of each Treatment Period | Terminal phase elimination half-life (T1/2) |
| Plasma Cmax after administration of tablet formulation in the fed and fasted states | From Day 1 to Day 3 of each Treatment Period | Maximum plasma concentration (Cmax) |
| Plasma AUC after administration of tablet formulation in the fed and fasted states | From Day 1 to Day 3 of each Treatment Period | Area under the concentration-time curve (AUC) |
| Plasma Tmax after administration of tablet formulation in the fed and fasted states | From Day 1 to Day 3 of each Treatment Period | Time to maximum plasma concentration (Tmax) |
| Plasma T1/2 after administration of tablet formulation in the fed and fasted states | From Day 1 to Day 3 of each Treatment Period | Terminal phase elimination half-life (T1/2) |
| Safety and tolerability including treatment-emergent AE and treatment-emergent SAE | From Day 1 to Day 7 | — |
Countries
United States
Outcome results
None listed