Bioequivalence of a biosimilar enoxaparin (Cloti-Xa™) and its innovator (Clexane^® ): A single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced study in healthy human subjects.

ABSTRACT: Currently, several biosimilars of low-molecular-weight heparins (LMWHs) with differing potencies are being developed and marketed globally. Thus, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule. The present study aimed to determine the bioequivalence of biosimilar (Cloti-Xa™) and innovator (Clexane^® ) formulations of enoxaparin sodium (40 mg/0.4 ml) in healthy human volunteers. It was conducted as a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic study (NCT05265676). The participants were sequentially and randomly administered subcutaneous injections of Cloti-Xa™ (test) and Clexane^® (reference), separated by a one-week washout period. To assess the A

SUBMITTER: Saxena S 

PROVIDER: S-EPMC9237834 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature