Type II Diabetes
Conditions
Keywords
CKD-393, Type II Diabetes
Brief summary
A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393
Detailed description
A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults
Interventions
DRUGCKD-393 formulation I
single, oral administration of 2 tablets under fed condition
DRUGCKD-393 formulation II
single, oral administration of 2 tablets under fed condition
DRUGD501, D759, H053
single, oral administration of 1 D501, 1 D759 and 2 H053 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 55 Years
Healthy volunteers
Yes
Inclusion criteria
\[Inclusion Criteria\] 1. Between 19 aged and 50 aged healthy adult 2. Body weight more than 55kg for male, more than 50kg for female 3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2 4. if female, the subject must satisfy more than one of the following: * subject who have reached menopause (no natural menstruation for at least 2 years.) * subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method) \[
Exclusion criteria
\] 1. Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness 2. Subject with one of the following laboratory test results * AST, ALT \> UNLx1.5 * eGRF \< 60 ml/min/1.73 m2 (MDRD formula) * immuno-serology test results in positive * Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg 3. Subject who has history of the following and the history may affect safety of the subject or result of this study * History of any prescription drug or herbal medicine within 14 days before first administration investigational products * History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products * History of drug-metabolizing induction/inhibition enzyme such as barbital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Maximum concentration of drug in plasma |
| AUClast | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Area under the plasma drug concentration-time curve to last concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Terminal elimination half-life |
| AUCinf | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Area under the plasma drug concentration-time curve from 0 to infinity |
| CL/F | 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Apparent Clearance |
| Vd/F | 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Apparent Volume of Distribution |
| Tmax | 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Time to maximum plasma concentration |
Countries
South Korea
Outcome results
None listed