Bioequivalence of a biosimilar enoxaparin sodium to Clexane after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers.

Purpose: To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers.

Patients And Methods: A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain) and Clexane (enoxaparin 100 mg manufactured by Sanofi, reference) separated by a 1-week washout period.