A Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of a Tablet Formulation of CKD-510 as Compared to Capsule and to Assess the Effect of Food on the CKD 510 Tablet Formulation in Healthy Subjects

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

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