NCT03363477

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

Demonstration of Pharmacodynamic Equivalence of Enoxaparin Rovi (100-mg Subcutaneous Injection) to Clexane® (100-mg Subcutaneous Injection) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-dose, randomized, double-blind, 2-period, 2 sequence crossover study. Subjects will be screened up to 30 days before the study begins and admitted to the clinic on Day -1 of Period 1 for baseline assessments. Before dosing on Day 1 of Period 1, subjects will be randomly assigned to a treatment sequence. Subjects will receive a single dose of study drug on Day 1 of each treatment period. On Day 1 of Period 1, subjects will receive a single dose by subcutaneous route of the assigned study drug: enoxaparin (100 mg/mL) 100-mg SC injection manufactured by Rovi Spain, or Clexane (100 mg/mL) 100-mg SC injection manufactured by Sanofi EU; after an overnight fasting period of at least 10 hours. Subjects will continue fasting for at least 4 hours after study drug administration. The washout period between administrations of study drug in each period will be at least 7 days. On Day 1 of Period 2, subjects will cross over to receive the dose of the other drug, after an overnight fasting period of at least 10 hours. The total duration of the study will be approximately 6 weeks.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Enoxaparin
DRUG	Clexane

Timeline

• Start date: 2015-09-25
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2017-12-06
• Last updated: 2017-12-06