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

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

Timeline

Start

2007-07

Primary completion

2007-11

Completion

2007-11

Publications

• Background Drouet L, Bal dit Sollier C, Martin J. Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. Am Heart J. 2009 Aug;158(2):177-84. doi: 10.1016/j.ahj.2009.05.022.

Drugs

Indications