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Venus Remedies Reports P-I Study Results of Enoxaparin Biosimilar to Prevent Arterial and Venous Thromboembolism

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Venus Remedies Reports P-I Study Results of Enoxaparin Biosimilar to Prevent Arterial and Venous Thromboembolism

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  • 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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