Pharmacokinetics and Safety of Fixed-Dose Versus Separate Enavogliflozin/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects.

ABSTRACT: Envlo (enavogliflozin) 0.3 mg, an SGLT2 inhibitor, was approved in Korea in 2022 for glycemic control in type 2 diabetes (T2DM). This study evaluates its safety, pharmacokinetics, and food effects. Healthy subjects (age ≥ 19, weight ≥ 50.0 kg, body mass index (BMI) 18.0-30.0 kg/m²) were enrolled. Study I was a randomized, two-way crossover study with an 8-day washout, where subjects received either a separate or a fixed-dose combination (FDC) of enavogliflozin 0.3 mg/gemigliptin 50 mg. Study II, a randomized, open-label, two-way crossover design with a 7-day washout, compared the food effect of a single dose of enavogliflozin in fed versus fasted after a high-fat meal. In study I, enavogliflozin reached peak plasma concentration at 1.25 h (median) in both groups. The mean half-l

SUBMITTER: Choi YS 

PROVIDER: S-EPMC12518504 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature