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Effects of ximelagatran, an oral direct thrombin inhibitor, r-hirudin and enoxaparin on thrombin generation and platelet activation in healthy male subjects

Troy C. Sarich, PhD^*,*, Michael Wolzt, MD, Ulf G. Eriksson, PhD, Christer Mattsson, PhD, Alice Schmidt, MD, Susanne Elg, MSc, Magnus Andersson, MSc, Maria Wollbratt, MSc, Gunnar Fager, MD, PhD and David Gustafsson, MD, PhD

^* AstraZeneca LP, Wilmington, Delaware, USA
Department of Clinical Pharmacology, Allgemeines Krankenhaus Wien, University of Vienna, Vienna, Austria
AstraZeneca R&D Mölndal, Mölndal, Sweden

View larger version (49K): [in a new window]   Figure 1 Geometric mean levels (95% confidence intervals) of prothrombin fragment 1+2 (F1+2) in shed blood from healthy male subjects by treatment group predose and 2, 4 and 10 h postdosing. Statistical comparisons between the treatment and control groups have been made at each time point. *p value < 0.05 vs. control.

View larger version (42K): [in a new window]   Figure 2 Geometric mean levels (95% confidence intervals) of thrombin-antithrombin complex (TAT) in shed blood from healthy male subjects by treatment group predose and 2, 4 and 10 h postdosing. Statistical comparisons between the treatment and control groups have been made at each time point. *p value < 0.05 vs. control.

View larger version (42K): [in a new window]   Figure 3 Geometric mean levels (95% confidence intervals) of ß-thromboglobulin (ß-TG) in shed blood from healthy male subjects by treatment group predose and 2, 4 and 10 h postdosing. Statistical comparisons between the treatment and control groups have been made at each time point. *p value < 0.05 vs. control.

View larger version (16K): [in a new window]   Figure 4 Geometric means (95% confidence intervals) of the ratios of the prothrombin fragment 1+2 (F1+2), thrombin-antithrombin complex (TAT) and ß-thromboglobulin (ß-TG) levels in shed blood collected after administration of 15-, 30- and 60-mg oral doses of ximelagatran compared with control (predose and 2, 4 and 10 h postdose) (n = 12 per marker; three doses x four time points). Predose ratios for each dose, when plasma concentrations are zero, are plotted at 0.001 µmol/l on the logarithmic scale.

View larger version (19K): [in a new window]   Figure 5 Mean (SD) venous blood activated partial thromboplastin time (aPTT; using TAS-aPTT method) values vs. time since oral ximelagatran (15, 30 and 60 mg).

View larger version (19K): [in a new window]   Figure 6 Mean (SD) melagatran plasma concentration (µmol/l) vs. time since oral administration of 15-, 30- and 60-mg doses of ximelagatran (n = 20 per group).