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

Phase 1 Completed 46 enrolled Rovi Pharmaceuticals Laboratories PRA Health Sciences · collab

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start: 2015-09-25
Primary completion: 2015-12-01
Completion: 2015-12-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	100 mg	Subcutaneous

Indications

No indication recorded.