Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

Objective: 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. Materials and methods: 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(2). 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(max) and AUC(0–t) was between 80.00 and 125.00%. Results: 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(max) and 100.67 – 105.15 h×IU/mL for the AUC(0–t) of Chemi Enoxaparin compared with those of Clexane, and for anti-FIIa activity, they were 86.65 – 96.73 IU/mL for the C(max) and 87.72 – 97.25 h×IU/mL AUC(0–t), 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. Conclusion: Chemi enoxaparin is bioequivalent to the reference enoxaparin, and both compounds show similar tolerability and safety profiles.