Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.
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
1. Healthy adults aged 19 to 55 years 2. Females must be menopause or surgical infertility 3. Signed informed consent form 4. Other inclusion criteria, as defined in the protocol
Exclusion criteria
1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder 2. Clinical laboratory test values are outside the accepted normal range at Screening * aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.25 times the upper limit of the normal range * Total Bilirubin \> 1.5 times the upper limit of the normal range * creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range * estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease) * Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis * systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg 3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization 4. Participated in a clinical trial within 90 days prior to 1st IP dosing 5. Not eligible to participate for the study at the discretion of Investigator 6. Other exclusive inclusion criteria, as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Metformin | 0 hour ~ 48 hour after drug administration | Maximum plasma concentration of Metformin |
| AUClast of Metformin | 0 hour ~ 48 hour after drug administration | Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 of Metformin | 0 hour ~ 48 hour after drug administration | Half-life of Metformin |
| AUCinf of Metformin | 0 hour ~ 48 hour after drug administration | Area under the plasma concentration of Metformin-time curve from time zero to infinity |
| Vd/F of Metformin | 0 hour ~ 48 hour after drug administration | Apparent volume of distribution of Metformin |
| CL/F of Metformin | 0 hour ~ 48 hour after drug administration | Apparent clearance of Metformin |
| Tmax of Metformin | 0 hour ~ 48 hour after drug administration | Time to reach maximum (peak) plasma concentration of Metformin following drug administration |
Countries
South Korea
Outcome results
None listed