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To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
Sponsor: Chong Kun Dang Pharmaceutical
Summary
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
Key Details
Gender
All
Age Range
19 Years - 54 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-07-04
Completion Date
2024-08-08
Last Updated
2024-07-10
Healthy Volunteers
Yes
Conditions
Interventions
CKD-383(Fed)
After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.
CKD-383(Fasted)
After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.