Methods
A randomized, double-blind, placebo- and active-controlled, single- and
multiple-dose study was conducted. Twelve subjects in each dose group
received a single dose (0.2, 0.5, 1.0, 2.0, or 5.0 mg) or multiple doses
(0.1, 0.3, 0.5, 1.0, or 2.0 mg once daily for 15 consecutive days) of
DWP16001, dapagliflozin 10 mg, or placebo, in a ratio of 8:2:2. Serial
blood samples and interval urine samples were collected for PK and PD
analyses. Safety and tolerability were assessed throughout the study
period.