NCT00622115

Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)

A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Primary objective: * to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects. Secondary objective(s): * to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH * to assess the tolerability of the different anticoagulation protocols

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Enoxaparin

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-02-22
• Last updated: 2011-03-15

Locations

1 site across 1 country: France