Healthy
Conditions
Brief summary
The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
Interventions
DRUGDWP16001
Tablets, Oral, once daily single dose
DRUGMetformin IR
Metformin IR 1000mg, Tablets, Oral, BID for 7 days
DRUGDWP16001+Metformin IR
Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male adults aged 19 to 50 years at the time of screening test * 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0 * Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study * Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.
Exclusion criteria
* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder * Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug * Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) * Clinical laboratory test values are outside the accepted normal range at screening * Other exclusive inclusion criteria, as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of DWP16001 | 0-72 hours | Peak Plasma Concetration |
| AUClast of DWP16001 | 0-72 hours | Area under the plasma concentration versus time curve |
| Cmax,ss of Metformin | 0-144 hours | Peak Plasma Concetration at steady-state |
| AUCτ,ss of Metformin | 0-144 hours | Area under the plasma concentration versus time curve at Tau, steady-state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fe of DWP 16001, DWP16001 Metabolites | 0-72 hours | Fraction of the drug excreted into the urine |
| Tmax of DWP 16001, Metformin, DWP16001 Metabolites | 0-144 hours | Time at Cmax |
| CLR of DWP 16001 | 0-144 hours | Renal clearance of the drug from plasma |
| AUC of DWP 16001, Metformin, DWP16001 Metabolites | 0-144 hours | Area under the plasma concentration versus time curve |
| T1/2 of DWP 16001, Metformin | 0-144 hours | — |
| CL/F of DWP 16001, Metformin | 0-144 hours | Apparent total clearance of the drug from plasma after oral administration |
Countries
South Korea
Outcome results
None listed