Dyslipidemias Clinical Trial
Official title:
A Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 After a Single Oral Dose in Healthy Male Subjects
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.
Sixteen male subjects are divided into two groups. A group of subjects are administered a
single oral dose of CKD-337 after ingesting high fat meal and the other take same
investigational product (IP) in fasting condition. Then their blood is drawn on a fixed
schedule to analyse bioavailability of CKD-337.
Finishing the first treatment period, the two groups switch food conditions and initiate the
second period. The group of people that were administered CKD-337 with food are then dosed
the same IP in fasting condition, and the other group undergo vice versa.
Each treatment period was separated by a washout period of at least 7 days.
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