A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05526742
- Run by
- Chong Kun Dang Pharmaceutical
- People needed
- 16
- Starts
- 2022-08-24
- Expected to finish
- 2022-09-13
- Last updated by the study team
- 2023-03-15
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Pharmacology Unit — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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