Int J Clin Pharmacol Ther. 2021 Nov;59(11):734-744. doi: 10.5414/CP204022.
The present study compared the bioavailability of subcutaneous (s.c.) Chemi Enoxaparin with Clexane (80 mg/0.8 mL) under fasting conditions in healthy subjects.
This study was an open-label, randomized, single-dose, two-treatment period crossover study. We included healthy male and female subjects aged 18 - 55 years with a body mass index of 18 - 30 kg/m. The primary pharmacodynamic endpoints were anti-FIIa and anti-FXa activity. Bioequivalence was achieved when the 95% confidence interval (CI) for the geometric means of C and AUC was between 80.00 and 125.00%.
47 subjects were randomized for the treatment sequences. The 95% CI of the ratios of the geometric least squared means of anti-FXa activity was 96.28 - 102.65 IU/mL for C and 100.67 - 105.15 h×IU/mL for the AUC of Chemi Enoxaparin compared with those of Clexane, and for anti-FIIa activity, they were 86.65 - 96.73 IU/mL for the C and 87.72 - 97.25 h×IU/mL AUC, which met the criterion for bioequivalence. The number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) was low, mostly of mild severity, and similar for both compounds.
Chemi enoxaparin is bioequivalent to the reference enoxaparin, and both compounds show similar tolerability and safety profiles.
本研究比较了健康受试者空腹状态下皮下（s.c.）给予 Chemi Enoxaparin 与 Clexane（80mg/0.8mL）的生物利用度。
这是一项开放标签、随机、单剂量、两周期交叉研究。我们纳入了年龄在 18-55 岁、体重指数在 18-30kg/m 的健康男性和女性受试者。主要药效学终点为抗 FIIa 和抗 FXa 活性。当 C 和 AUC 的几何均数的 95%置信区间（CI）在 80.00 和 125.00%之间时，即可达到生物等效性。
47 名受试者按治疗顺序随机分组。抗 FXa 活性的几何均数最小二乘比的 95%CI 为 Chemi Enoxaparin 的 C 值为 96.28-102.65IU/mL，AUC 值为 100.67-105.15h×IU/mL，与 Clexane 相比，抗 FIIa 活性的 C 值为 86.65-96.73IU/mL，AUC 值为 87.72-97.25h×IU/mL，均符合生物等效性标准。报告至少 1 例治疗期间出现的不良事件（TEAE）的受试者人数较少，大多数为轻度，两种药物的不良反应发生率相似。
Chemi enoxaparin 与参比依诺肝素具有生物等效性，且两者具有相似的耐受性和安全性特征。
