A pharmacokinetic and pharmacodynamic drug-drug interaction study of dorzagliatin and empagliflozin in patients with type 2 diabetes and obesity: an open-label phase I trial

of empagliflozin and dorzagliatin of pharmacokinetic parameters and the incidence of adverse events, abnormal vital signs, abnormal clinical laboratory findings, and 12-lead electrocardiogram abnormalities of safety profile. A total of 27 adverse events occurs in 9 participants (56.3%), the majority of which are mild, with the exception of one case of moderate constipation. No clinically significant findings or changes attributable to study drug treatment were found in clinical chemistry, hematology and urinary analyses, and observed in vital signs, 12-lead electrocardiogram and physical examination. The geomean ratio and their associated 90% confidence intervals for both maximum plasma concentration (empagliflozin: 98.43% (84.07%, 115.25%); dorzagliatin: 103.94% (90.45%, 119.44%)) and area under the concentration-time curve from 0 to 24 h (empagliflozin: 97.53% (94.35%, 100.82%); dorzagliatin: 99.65% (95.25%, 104.25%)) of empagliflozin and dorzagliatin fall entirely within the conventional bioequivalence range of 80.00% to 125.00%. No pharmacokinetic drug-drug interaction is observed, and the treatment exhibits a favorable safety profile with good overall tolerability.