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Study of Pharmacodynamic Equivalence of Enoxaparin Rovi to Clexane®, in Healthy Volunteers

NCT03363477 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-12-06

No results posted yet for this study

Summary

To demonstrate the pharmacodynamic (PD) equivalence of enoxaparin Rovi (100 mg/mL) 100-mg SC injection to Clexane® (100 mg/mL) 100-mg SC injection in healthy volunteers.

As secondary objective, to evaluate the safety and tolerability of enoxaparin Rovi (100 mg/mL) in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

Enoxaparin

DRUG

Clexane

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Rovi Pharmaceuticals Laboratories

    lead INDUSTRY

Principal Investigators

  • Maria Velinova, MD, PhD · PRA Health Sciences (PRA) - Early Development Services (EDS)

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
2015-09-25
Primary Completion
2015-12-01
Completion
2015-12-01

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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 NCT03363477 on ClinicalTrials.gov