Lee Sooyoung, Chae Sumin, Kwon Minji, Shim Wang-Seob, Lee Kyung-Tae, Yim Sung-Vin, Kim Bo-Hyung
Department of Life and Nanopharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Department of Surgery, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.
Drug Des Devel Ther. 2025 Sep 6;19:7825-7836. doi: 10.2147/DDDT.S526915. eCollection 2025.
This study aimed to evaluate the pharmacokinetics and pharmacodynamics of metformin and Ojeok-san (OJS) co-administration to healthy volunteers compared to those with metformin alone.
This was an open-label, one-sequence, crossover study, with two 2-day hospitalization schedules lasting up to 14 days. Metformin was administered once daily on days 1 and 2. OJS was administered alone three times a day on days 3-7 and co-administered with metformin once a day on days 8 and 9. Plasma concentrations of metformin were measured using a validated LC-MS/MS method. To evaluate pharmacodynamics, oral glucose tolerance tests (OGTTs) were performed on days 1, 2, 8 and 9.
Fifteen participants were enrolled. The coadministration decreased C (1757.7 to 1668.9 ng/mL) and AUC (10407.4 to 9901.1 ng·h/mL), compared to those with metformin alone. Geometric mean ratios (90% Confidence Interval) of C and AUC between the co-administration with OJS and metformin alone were 92.15% (82.79-102.57) and 94.57% (85.6-104.48), respectively. Co-administration with OJS did not significantly change the mean glucose level compared to that with metformin alone.
Co-administration with OJS decreased the plasma concentrations of metformin compared to that with metformin alone. However, the degree of decrease was not significant based on the geometric mean of the C and AUC. Considering the OGTT results, these changes in metformin concentration did not affect glucose concentration. In addition, there were no significant findings regarding safety profiles.
本研究旨在评估与单独使用二甲双胍相比，二甲双胍与玉烛散（OJS）联合给药对健康志愿者的药代动力学和药效学影响。
这是一项开放标签、单序列、交叉研究，有两个为期2天的住院安排，最长持续14天。在第1天和第2天每天服用一次二甲双胍。在第3 - 7天，OJS单独每天服用三次，在第8天和第9天与二甲双胍联合每天服用一次。使用经过验证的液相色谱 - 串联质谱法（LC - MS/MS）测量二甲双胍的血浆浓度。为评估药效学，在第1天、第2天、第8天和第9天进行口服葡萄糖耐量试验（OGTT）。
招募了15名参与者。与单独使用二甲双胍相比，联合给药降低了C（从1757.7降至1668.9 ng/mL）和AUC（从10407.4降至9901.1 ng·h/mL）。与单独使用二甲双胍相比，OJS与二甲双胍联合给药时C和AUC的几何平均比值（90%置信区间）分别为92.15%（82.79 - 102.57）和94.57%（85.6 - 104.48）。与单独使用二甲双胍相比，与OJS联合给药并未显著改变平均血糖水平。
与单独使用二甲双胍相比，与OJS联合给药降低了二甲双胍的血浆浓度。然而，基于C和AUC的几何平均值，降低程度并不显著。考虑到OGTT结果，二甲双胍浓度的这些变化并未影响血糖浓度。此外，在安全性方面没有显著发现。
