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Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox®

NCT04402762 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-05-27

No results posted yet for this study

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.

Conditions

  • Enoxaparin

Interventions

DRUG

Ovine Enoxaparin

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.

DRUG

Enoxaparin Prefilled Syringe [Lovenox]

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.

Sponsors & Collaborators

  • PT Metiska Farma

    collaborator UNKNOWN

  • Indonesia University

    lead OTHER

Principal Investigators

  • Arini Setiawati, Prof, PhD · Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2020-04-17
Completion
2020-05-03

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402762 on ClinicalTrials.gov