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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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Pregnant Patients with Deep Venous Thrombosis: Management and the Incidence of Thrombophilic Risk Factors

There is lack of knowledge about anticoagulant therapy in pregnancy and an acceptable guide for their use is based on case series and the opinion of scientists. For this reason, we carried out a study on pregnant women suffering from acute deep venous thrombosis (DVT) using enoxaparin twice daily dose.
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