Type II Diabetes Mellitus
Conditions
Brief summary
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination
Detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions
Interventions
DRUGCKD-379
2 tablet administration under fed condition
DRUGD759+D745+D029+D150
4 tablet co-administration under fed condition
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 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 19 aged and 50 aged in healthy adult * 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg
Exclusion criteria
* Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system * Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery * Those who are pregnant or breastfeeding * Those who are deemed inappropriate to participate in clinical trial by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt | 0~48hours | Maximum plasma concentration of the drug |
| Cmax | 0~48hours | Area under the concentration-time curve from the time of dosing to the last measurable concentration |
Countries
South Korea
Outcome results
None listed