FDC, Diabetes Mellitus, Type 2
Conditions
Brief summary
To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.
Interventions
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Chungbuk University Hospital to participate in this study according to his free will. 2. Healthy adults aged 19 or older at the time of screening. 3. Those who weigh more than 50.0 kg in men and women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women. * Body mass index (BMI) = Weight (kg) / \[Height (m)\] 2.
Exclusion criteria
1. A person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc. 2. A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia). 3. Those who are hypersensitive to other drugs (DPP-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including DWP16001, DWC202213 and homogeneous (SGLT2 inhibitors) 4. A person who shows the following results in the inspection items conducted during screening. * Blood ALT, AST, Total bilirubin \> twice the upper limit of the normal range. * The glomerular filtration rate (e-GFR) \<90 mL/min/1.73 m2 (using the CKD-EPI method) 5. After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<60 mmHg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t of DWP16001 | 0 to 24 hours | AUC0-t of DWP16001 |
| Cmax of DWP16001 | 0 to 24 hours | Cmax of DWP16001 |
| AUC0-t of DWC202213 | 0 to 24 hours | AUC0-t of DWC202213 |
| Cmax of DWC202213 | 0 to 24 hours | Cmax of DWC202213 |
Countries
South Korea
Contacts
Primary ContactJun Gi Hwang, MD, PhD
Outcome results
None listed