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.

ABSTRACT:

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. The primary PK/PD variables were maximum activity (A_max) and area under the effect curve from time 0 to the last measured activity (T) (AUEC_0-T) and AUEC from t

SUBMITTER: Martinez Gonzalez J 

PROVIDER: S-EPMC5865560 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature