Type2Diabetes
Conditions
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
Interventions
DRUGCKD-393(2)
QD, PO
DRUGCKD-501, D759, D150, D029
QD, PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult volunteers aged 19 ≤ \ \< 55-year-old. 2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ \ \< 30.5 kg/m2. 3. Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings. 4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Exclusion criteria
1. 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. 2. 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. 3. Those who are pregnant or breastfeeding. 4. Those who are deemed inappropriate to participate in clinical trial by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt | Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours | Area under the concentration-time curve from time zero to time |
| Cmax | Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours | Maximum plasma concentration of the drug |
Countries
South Korea
Outcome results
None listed