Meng Xue, Oh Eun Sil, Park Min Soo, Kim Dasohm, Kim Jeong Hoon, Kim Choon Ok
Department of Pharmaceutical Medicine and Regulatory Sciences, Colleges of Medicine and Pharmacy, Yonsei University, Incheon 21983, Republic of Korea.
Department of Clinical Pharmacology and Clinical Trials Center, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Republic of Korea.
Transl Clin Pharmacol. 2017 Dec;25(4):196-201. doi: 10.12793/tcp.2017.25.4.196. Epub 2017 Dec 20.
JOINS (SKI306X) is an herbal anti-arthritic medicine that is widely used with aceclofenac for treating osteoarthritis in Korea. A fixed-dose combination (FDC) tablet containing SKI306X and aceclofenac was developed to improve patient compliance. This study aimed to compare the pharmacokinetics (PK) and safety of the FDC tablet with those of co-administered SKI306X and aceclofenac in healthy subjects. In this randomized, open-label, two-way crossover, single-dose study, the FDC tablet (SKI306X 300 mg/aceclofenac 100 mg) (test) was given or co-administration of 300 mg of SKI306X and 100 mg of aceclofenac (reference) was performed followed by a 7-day wash-out period. Blood samples were collected before and after drug administration to evaluate aceclofenac PK parameters, and safety was assessed throughout the study. A total of 54 healthy male subjects were enrolled in and completed the study. T and t of aceclofenac of the FDC tablet were similar to those of aceclofenac co-administered with SKI306X (T: test 2.96 h and reference 2.14 h; t: test 3.46 h and reference 4.04 h). The geometric mean ratios (90% confidence intervals) of C and AUC (T/R) were 0.85 (0.81 to 0.91) and 1.03 (1.01 to 1.06) respectively; these results were within the predefined range (0.8 to 1.25). There was only one drug-related adverse event (dizziness) occurred after administration of the FDC tablet; however, it was mild in severity and resolved without any complications. The FDC tablet was well tolerated and exhibited an absorption rate and extent comparable to those of SKI306X and aceclofenac administered simultaneously.
JOINS（SKI306X）是一种草药抗关节炎药物，在韩国与醋氯芬酸一起广泛用于治疗骨关节炎。为提高患者依从性，研发了一种含有SKI306X和醋氯芬酸的固定剂量复方（FDC）片剂。本研究旨在比较FDC片剂与在健康受试者中联合给药的SKI306X和醋氯芬酸的药代动力学（PK）及安全性。在这项随机、开放标签、双向交叉、单剂量研究中，给予FDC片剂（SKI306X 300毫克/醋氯芬酸100毫克）（试验组），或进行300毫克SKI306X与100毫克醋氯芬酸的联合给药（对照组），随后有7天的洗脱期。在给药前后采集血样以评估醋氯芬酸的PK参数，并在整个研究过程中评估安全性。共有54名健康男性受试者纳入并完成了该研究。FDC片剂中醋氯芬酸的T和t与与SKI306X联合给药时醋氯芬酸的T和t相似（T：试验组2.96小时，对照组2.14小时；t：试验组3.46小时，对照组4.04小时）。C和AUC（试验组/对照组）的几何平均比值（90%置信区间）分别为0.85（0.81至0.91）和1.03（1.01至1.06）；这些结果在预定义范围内（0.8至1.25）。服用FDC片剂后仅发生1例药物相关不良事件（头晕）；然而，其严重程度较轻，且无任何并发症自行缓解。FDC片剂耐受性良好，其吸收速率和程度与同时给予SKI306X和醋氯芬酸时相当。
