Pharmacokinetics and Safety of Fixed-Dose Versus Separate Enavogliflozin/Gemigli...

연구 요약

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

Clinical and translational science 학술지에 발표된 이 연구는 Choi YS, Na J, Park SY 외 연구팀이 수행하였습니다.

이 연구는 'Pharmacokinetics and Safety of Fixed-Dose Versus Separate Enavogliflozin/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects.'에 대한 과학적 분석을 제공합니다.

핵심 내용

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-life (t1/2) was also comparable, recorded as 12.56 ± 4.04 h for the separate combination and 12.23 ± 3.46 h for the FDC. Gemigliptin peaked at 2.00 h in the separate combination and at 3.00 h in the FDC. The mean t1/2 was 18.04 ± 1.75 h for the separate combination and 18.67 ± 2.54 h for the FDC. In study II, the plasma concentration of enavogliflozin 0.3 mg peaked at 1.25 and 2.00 h (median), indicating a delayed Tmax in the fed group. The average t1/2 was similar at 12.49 ± 2.12 h and 12.30 ± 2.81 h, respectively. The FDC of enavogliflozin and gemigliptin demonstrated pharmacokinetic equivalence and comparable safety to their co-administration as separate agents. Furthermore, the systemic exposure of enavogliflozin was not affected by food intake, supporting its potential for flexible, meal-independent use in clinical settings.

일반인을 위한 해석

구체적인 실천 사항은 담당 의사 또는 약사와 상담하시기 바랍니다.

실천 사항

• 현재 복용 중인 약물이나 영양제에 대해 궁금한 점이 있다면 담당 의사 또는 약사와 상담하시기 바랍니다
• 약물이나 영양제의 용법·용량을 임의로 변경하지 마세요
• 이상 반응이 나타나면 즉시 전문가에게 문의하세요

의사/약사의 전문적 판단을 대체하지 않습니다 (PMID: 41084226)

📄 [전문 보기 (Markdown)](fulltext/41084226-pharmacokinetics-and-safety-of-fixed-dose-versus-separate-en.md)