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

NCT05265676 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-03-03

No results posted yet for this study

Summary

This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited, India) and its innovator product (Clexane®, Sanofi, Germany).

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

Sponsors & Collaborators

  • Venus Remedies Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Mayur Soni · Cliantha Research Limited, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2021-03-07
Completion
2021-03-11

Countries

  • India

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 NCT05265676 on ClinicalTrials.gov