| Autor: |
Paccaly, Anne, Frick, Annke, Rohatagi, Shashank, Liu, Jingli, Shukla, Umesh, Rosenburg, Ronald, Hinder, Markus, Jensen, Bradford K. |
| Zdroj: |
Journal of Clinical Pharmacology; Jan2006, Vol. 46 Issue 1, p37-44, 8p |
| Abstrakt: |
The pharmacokinetics of otamixaban was investigated in healthymale subjects over a wide range of intravenous doses, with duration of administration varying between 1-minute infusions (bolus dose) and 24-hour infusions, using noncompartmental and multicompartmental methods. A global compartmental analysis (2 and 3 compartments) generated a single set of pharmacokinetic parameters, regardless of infusion rate and duration, and took into account the 30% decrease in clearance and volume of distribution observed over the dose range. The 2-compartment model was retained to predict bolus plus 3-hour-infusion doses of otamixaban for future phase 2/3 studies. Otamixaban exhibited in healthy subjects several interesting pharmacokinetic features in view of its potential therapeutic use in coronary thrombosis: a rapid plasma distribution and elimination, a well-described dose-exposure relationship, a low intersubject variability in plasma exposure, and a mixed renal and biliary excretion with constant renal clearance. [ABSTRACT FROM PUBLISHER] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
|
Plný text