CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Ovine Enoxaparin +1 moredrug
Likely dose
Ovine Enoxaparin 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04402762
NCT04402762Phase 2Completed
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Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin (Lovenox®) in Healthy Volunteers

Indonesia University·interventional·Posted May 27, 2020·Updated May 27, 2020

In Brief

A Phase 2 clinical trial evaluating Ovine Enoxaparin and Enoxaparin Prefilled Syringe [Lovenox] for Enoxaparin. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnoxaparin
CountriesIndonesia
CollaboratorsPT Metiska Farma

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 27, 2020
Enrollment StartDec 20, 2019
Primary CompletionApr 17, 2020
Study CompletionMay 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 years ago

Interventions

Ovine Enoxaparindrug

The test drug is ovine enoxaparin sodium 60 mg (0.6 mL taken from 1.0 mL vial containing 100 mg = 10,000 IU anti-FXa), from Metiska Farma.

Enoxaparin Prefilled Syringe [Lovenox]drug

The reference drug is enoxaparin sodium 60 mg (Lovenox® 0.6 mL prefilled syringe containing 60 mg = 6,000 IU anti-FXa) from Sanofi, France.