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No Pharmacokinetic or Pharmacodynamic Interaction Between Digoxin and the Oral Direct Thrombin Inhibitor Ximelagatran in Healthy Volunteers

From Experimental Medicine, AstraZeneca LP, Wilmington, Delaware (Dr. Sarich) and Experimental Medicine, AstraZeneca R&D Mölndal, Sweden (Dr. Schützer, Ms. Wollbratt, Dr. Wall, Ms. Kessler, Dr. Eriksson).

The interaction potential of digoxin and ximelagatran, an oral direct thrombin inhibitor being developed for the prevention and treatment of thromboembolic disease, was investigated in this randomized, double-blind, 2-way crossover study. On 2 separate occasions, healthy female and male volunteers (n = 16) received ximelagatran 36 mg or placebo twice daily for 8 days separated by a 4- to 14-day washout period. All volunteers received a single oral dose of digoxin 0.5 mg on day 4 of both study periods. No interaction between ximelagatran and digoxin was detected in the pharmaco-kinetic parameters (using a 90% confidence interval [CI] of least squares mean estimate ratios), including melagatran (the active form of ximelagatran) AUC and C_max and digoxin AUC_t and C_max. Digoxin did not alter the melagatran-induced prolongation of the activated partial thromboplastin time, and both drugs were well tolerated when administered in combination. In conclusion, no pharmacokinetic or pharmacodynamic interaction between digoxin and ximelagatran was observed in this study.

Key Words: Digoxin • ximelagatran • drug interactions • oral direct thrombin inhibitors • thromboembolic disease

Address for reprints: Troy C. Sarich, PhD, Experimental Medicine, AstraZeneca LP, C4C-123, P.O. Box 15437, 1800 Concord Pike, Wilmington, DE 19850.

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