Status:
COMPLETED
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type2Diabetes
Eligibility:
All Genders
19-54 years
Phase:
PHASE1
Brief Summary
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Detailed Description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions
Eligibility Criteria
Inclusion
- Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
- Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
- Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Exclusion
- Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
- Those who are pregnant or breastfeeding.
- Those who are deemed inappropriate to participate in clinical trial by investigators.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05347576
Start Date
April 21 2022
End Date
May 9 2022
Last Update
June 30 2022
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea