Dataset Information

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

ABSTRACT:

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 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.

SUBMITTER: Febbraro S

PROVIDER: S-EPMC8554289 | biostudies-literature |

REPOSITORIES: biostudies-literature

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