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Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin (Lovenox®) In Healthy Volunteers: A Randomized, Open-Label, 2-Way Cross-Over, Single Dose Study

Aim: to demonstrate the PK/PD equivalence of an ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers with s.c. administration. Methods: a randomized, open-label, 2-way cross-over, single-dose study with 7 days wash-out period was conducted in healthy volunteers of both sexes. A single s.c. injection of 6,000 IU ovine enoxaparin from Metiska Farma (the test drug, T) or Lovenox® from Sanofi (the reference drug, R) was given randomly to each subject in fasting condition. The PD endpoints measured were anti-FXa and anti-FIIa activities in plasma, whereas the PD parameters determined for these endpoints were AUEC0-t (area under the effect curve from time 0 to the last measured activity (t)) and Amax (maximum activity). Bioequivalence (BE) is based on anti-FXa activity, the 90% CIs for GMR T/R (geometric means ratio of Test/ Reference) of AUEC0-t and Amax must fall within the BE limits of 80.00 – 125.00%. The anti-FIIa data are in vivo supportive evidence only. Results: a total of 23 healthy volunteers completed this study. The 90% CIs for GMR T/R of AUEC0-t and Amax for anti-FXa were 107.55 – 116.33% and 110.17 – 117.68%, respectively, while those for anti-FIIa were 100.93 – 122.56% and 105.19 – 124.44%, respectively. All parameters fell within the BE criteria of 80.00 – 125.00%. One AE (adverse event) occurred in one volunteer after s.c. injection of ovine enoxaparin, i.e. bruising which disappeared after a few days. Conclusions: the ovine enoxaparin from Metiska Farma was bioequivalent to the reference porcine enoxaparin (Lovenox®) from Sanofi. Both enoxaparin products were shown to have high safety and tolerability after a single dose in healthy volunteers. This is the first study showing BE of a nonporcine enoxaparin to the reference porcine enoxaparin in Indonesia, a Moslem country
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