Venus Remedies Reports P-I Study Results of Enoxaparin Biosimilar to Prevent Arterial and Venous Thromboembolism
Shots:
- The P-I crossover, balanced, single-dose PD study evaluates enoxaparin sodium biosimilar Cloti-Xa vs Clexane in 24 male healthy volunteers aged 35yrs. After the administration of the study drugs, many blood samples were obtained over the next 24hrs.
- The results showed a similar PD & PK profiles of enoxaparin sodium biosimilar Cloti-Xa vs reference Clexane & Lovenox & also showed anti-factor Xa and anti-factor IIa activity within predefined bioequivalence margins, 90% CIs for TFPI & aPTT were within the bioequivalence margins excl. AUECt for aPTT
- Both biosimilar & reference Clexane were well-tolerated with no serious AEs. Enoxaparin sodium is low-molecular-weight heparin & an antithrombotic medication indicated for arterial & VTE
Ref: Centre for Biosimilars | Image: Venus Remedies
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