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/m2. 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 Cmax and AUC0-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 Cmax and 100.67 - 105.15 h×IU/mL for the AUC0-t of Chemi Enoxaparin compared with those of Clexane, and for anti-FIIa activity, they were 86.65 - 96.73 IU/mL for the Cmax and 87.72 - 97.25 h×IU/mL AUC0-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.