Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox®

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 20, 2019

Primary Completion Date

April 17, 2020

Study Completion Date

May 3, 2020

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.

Trial Locations (1)

10520

Pharma Metric Labs, Jakarta Pusat

All Listed Sponsors
collaborator

PT Metiska Farma

UNKNOWN

lead

Indonesia University

OTHER

NCT04402762 - Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox® | Biotech Hunter | Biotech Hunter