Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 26, 2021

Primary Completion Date

March 7, 2021

Study Completion Date

March 11, 2021

Conditions
Healthy
Interventions
DRUG

Enoxaparin Sodium (Venus Remedies Limited)

The test drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Venus Remedies Limited, India

DRUG

Enoxaparin Sodium (Sanofi)

The reference drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Sanofi, Germany

Trial Locations (1)

380054

Cliantha Research Limited, Ahmedabad

All Listed Sponsors
lead

Venus Remedies Limited

INDUSTRY

NCT05265676 - Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects | Biotech Hunter | Biotech Hunter