The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Tablets, Oral, once daily single dose
Metformin IR 1000mg, Tablets, Oral, BID for 7 days
Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
Seoul National University Hospital
Seoul, South Korea
Cmax of DWP16001
Peak Plasma Concetration
Time frame: 0-72 hours
AUClast of DWP16001
Area under the plasma concentration versus time curve
Time frame: 0-72 hours
Cmax,ss of Metformin
Peak Plasma Concetration at steady-state
Time frame: 0-144 hours
AUCτ,ss of Metformin
Area under the plasma concentration versus time curve at Tau, steady-state
Time frame: 0-144 hours
Tmax of DWP 16001, Metformin, DWP16001 Metabolites
Time at Cmax
Time frame: 0-144 hours
AUC of DWP 16001, Metformin, DWP16001 Metabolites
Area under the plasma concentration versus time curve
Time frame: 0-144 hours
T1/2 of DWP 16001, Metformin
Time frame: 0-144 hours
CL/F of DWP 16001, Metformin
Apparent total clearance of the drug from plasma after oral administration
Time frame: 0-144 hours
fe of DWP 16001, DWP16001 Metabolites
Fraction of the drug excreted into the urine
Time frame: 0-72 hours
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CLR of DWP 16001
Renal clearance of the drug from plasma
Time frame: 0-144 hours