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

Launched by CHONG KUN DANG PHARMACEUTICAL · Aug 31, 2022

Keywords

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Gender

ALL

Eligibility criteria

• 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