Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.
Interventions
DRUGCKD-375
Test drug
DRUGD387
Reference drug
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
1. Healthy adults aged 19 to 55 years 2. Females who are not pregnant or breastfeeding or who have 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 3. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge. 4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge. 5. Participated in a clinical trial within 90 days prior to 1st IP dosing 6. Not eligible to participate for the study at the discretion of Investigator 7. Other exclusive inclusion criteria, as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration of Empagliflozin | Time Frame: 0 hour ~ 48 hour after drug administration | Cmax of Empagliflozin |
| Maximum plasma concentration of Metformin | Time Frame: 0 hour ~ 48 hour after drug administration | Cmax of Metformin |
| Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration | Time Frame: 0 hour ~ 48 hour after drug administration | AUClast of Empagliflozin |
| Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration | Time Frame: 0 hour ~ 48 hour after drug administration | AUClast of Metformin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Half-life of Empagliflozin | 0 hour ~ 48 hour after drug administration | t1/2 of Empagliflozin |
| Half-life of Metformin | 0 hour ~ 48 hour after drug administration | t1/2 of Metformin |
| Apparent clearance of Empagliflozin | 0 hour ~ 48 hour after drug administration | CL/F of Empagliflozin |
| Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity | 0 hour ~ 48 hour after drug administration | AUCinf of Empagliflozin |
| Apparent volume of distribution of Empagliflozin | 0 hour ~ 48 hour after drug administration | Vd/F of Empagliflozin |
| Apparent volume of distribution of Metformin | 0 hour ~ 48 hour after drug administration | Vd/F of Metformin |
| Apparent clearance of Metformin | 0 hour ~ 48 hour after drug administration | CL/F of Metformin |
| Area under the plasma concentration of Metformin-time curve from time zero to infinity | 0 hour ~ 48 hour after drug administration | AUCinf of Metformin |
| Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration | 0 hour ~ 48 hour after drug administration | Tmax of Empagliflozin |
| Time to reach maximum (peak) plasma concentration of Metformin following drug administration | 0 hour ~ 48 hour after drug administration | Tmax of Metformin |
Contacts
Primary ContactKyung-Sang Yu, M.D.,Ph.D
Backup ContactSoyoung Lee, Pharmacist
Outcome results
None listed