Overview

Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox®

Status:
Completed
Trial end date:
2020-05-03
Target enrollment:
Participant gender:
Summary
This study is designed as a randomized, open-label, 2-way cross-over, single dose study with at least 7 days wash-out period. The objective of this study is to demonstrate the pharmacodynamic / pharmacokinetic equivalence of ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Indonesia University
Collaborator:
PT Metiska Farma
Treatments:
Enoxaparin
Enoxaparin sodium