Beijing Daewoong Weiye Pharmaceutical Science & Technology

Main purpose 1) To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of [14C]DWP14012, and obtain the human radioactivity recovery rate data and the main excretion pathway; 2) To identify the main metabolites in the human body after oral administration of [14C]DWP14012 to male healthy subjects, and determine the main biotransformation pathways; 3) To investigate the distribution ratio of total radioactivity in whole blood and plasma and the pharmacokinetic characteristics of total radioactivity in plasma after a single oral administration of [14C]DWP14012 to male healthy subjects; 4) To quantitatively analyze the concentrations of DWP14012 and metabolite M14 and other metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of DWP14012 and metabolite M14 and other metabolites (if applicable) in plasma; Secondary purpose To observe the safety of male healthy subjects after a single dose of [14C]DWP14012

DB study: To demonstrate the non-inferiority of DWP16001 to dapagliflozin in combination with metformin in patients with T2DM who have inadequate glycemic control on metformin alone, and to evaluate the safety of DWP16001 in combination with metformin OLE study: The purpose of this study is to evaluate the long-term safety and efficacy of DWP16001 in combination with metformin in patients with T2DM who have inadequate glycemic control on metformin alone.

To evaluate the efficacy, safety and cost-effectiveness of DWP14012 40 mg in the treatment of reflux esophagitis compared with esomeprazole magnesium enteric-coated tablets.