No effect of encapsulation on the pharmacokinetics of warfarin

Biopharmaceutics and Drug Disposition

Volumn 26, Issue 3, 2005, Pages 121-127

  Johansson, Susanne ^a   Ohlsson, Lis ^a   Stenhoff, Helene ^a   Wåhlander, Karin ^a   Cullberg, Marie ^a  

^a ASTRAZENECA R AND D   (Sweden)

Author keywords

Bioequivalence; Pharmacokinetics; R and S warfarin

Indexed keywords

AMIODARONE; ATORVASTATIN; DIAZEPAM; DICLOFENAC; DIGOXIN; NIFEDIPINE; THROMBIN INHIBITOR; WARFARIN; XIMELAGATRAN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG COATING; ENCAPSULATION; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET;

ADMINISTRATION, ORAL; ADULT; BIOLOGICAL AVAILABILITY; CAPSULES; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; STEREOISOMERISM; THERAPEUTIC EQUIVALENCY; WARFARIN;

EID: 17844393129     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.441     Document Type: Article

References (30)

1. Bates SM, Weitz JI. Emerging anticoagulant drugs. Arterioscler Thromb Vasc Biol 2003; 23: 1491-1500.
2. Da Silva MS, Sobel M. Anticoagulants: To bleed or not to bleed, that is the question. Semin Vasc Surg 2002; 15: 256-267.
3. Pinede L, Duhaut P, Ninet J. Management of oral anticoagulants in the treatment of venous thromboembolism. Eur J Intern Med 2001; 12: 75-85.
4. Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: 1816-1828.
5. Hirsh J. Current anticoagulant therapy - unmet clinical needs. Thromb Res 2003; 109 (Suppl 1): S1-S8.
6. Gustafsson D, Elg M. The pharmacodynamics and pharmacokinetics of the oral direct thrombin inhibitor ximelagatran and its active metabolite melagatran: a mini-review. Thromb Res 2003; 109: S9-S15.
7. Bredberg E, Andersson TB, Frison L, et al. Ximelagatran, an oral direct thrombin inhibitor, has a low potential for cytochrome P450-mediated drug-drug interactions. Clin Pharmacokinet 2003; 42: 765-777.
8. Sarich TC, Johansson S, Schützer K-M, et al. The pharmacokinetics and pharmacodynamics of ximelagatran, an oral direct thrombin inhibitor, are unaffected by a single dose of alcohol. J Clin Pharmacol 2004; 44: 388-393.
9. Sarich TC, Schützer KM, Dorani H, et al. No pharmacokinetic or pharmacodynamic interaction between atorvastatin and the oral direct thrombin inhibitor ximelagatran. J Clin Pharmacol 2004; 44: 928-934.
10. Sarich TC, Schützer K-M, Wollbrat M, et al. No pharmacokinetic or pharmacodynamic interaction between digoxin and the oral direct thrombin inhibitor ximelagatran in healthy subjects. J Clin Pharmacol 2004; 44: 935-941.
11. Teng R, Sarich TC, Eriksson UG, et al. A pharmacokinetic study of combined administration of amiodarone and ximelagatran, an oral direct thrombin Inhibitor. J Clin Pharmacol 2004; 44: 1063-1071.
12. Eriksson BI, Agnelli G, Cohen AT, et al. Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement. The METHRO III study. Thromb Haemost 2003; 89: 288-296.
13. Eriksson BI, Agnelli G, Cohen AT, et al., on behalf of the EXPRESS Study Group. The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study. J Thromb Haemost 2003; 1: 2490-2496.
14. Francis CW, Berkowitz SD, Comp PC, et al., for the EXULT A Study Group. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement: EXULT A. N Engl J Med 2003; 349: 1703-1712.
15. Colwell CW, Berkowitz SD, Comp PC, et al. and EXULT B Investigators. Randomized, double-blind comparison of ximelagatran, an oral direct thrombin inhibitor, and warfarin to prevent venous thromboembolism (VTE) after total knee replacement (TKR): EXULT B. Blood 2003; 102: 14a. Abstract No. 39.
16. Francis CW, Ginsberg JS, Berkowitz SD, et al., and the THRIVE Treatment Study Investigators. Efficacy and safety of the oral direct thrombin inhibitor ximelagatran compared with current standard therapy for acute, symptomatic deep vein thrombosis, with or without pulmonary embolism: The THRIVE treatment study. Blood 2003; 102 6a. Abstract No. 7.
17. Schulman S, Wåhlander K, Lundström T, et al. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med 2003; 349: 1713-1721.
18. Executive Steering Committee on behalf of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003; 362: 1691-1698.
19. The Executive Steering Committee on behalf of the SPORTIF V Investigators. Stroke prevention using the oral direct thrombin inhibitor ximelagatran in patients with nonvalvular atrial fibrillation (SPORTIF V). Circulation 2003; 108: 2723(J).
20. Wallentin L, Wilcox RG, Weaver WD, et al; ESTEEM Investigators. Efficacy and safety of long term treatment with the oral direct thrombin inhibitor ximelagatran, in combination with acetylsalicylic acid, in patients with a recent acute myocardial infarction: the ESTEEM trial. Lancet 2003; 362: 789-797.
21. Milliken GA, Johnson DE. Analysis of Messy Data, Volume 1: Designed Experiments. Belmont, CA: Lifetime Learning Publications; 1984.
22. Hignite C, Uetrecht J, Tschanz C, Azarnoff D. Kinetics of R and S warfarin enantiomers. Clin Pharmacol Ther 1980; 28: 99-105.
23. Kim JS, Nafziger AN, Gaedigk A, et al. Effects of oral vitamin K on S- and R-warfarin pharmacokinetics and pharmacodynamics: enhanced safety of warfarin as a CYP2C9 probe. J Clin Pharmacol 2001; 41: 715-722.
24. Palareti G, Legnani C. Warfarin withdrawal. Pharmacokinetic-pharmacodynamic considerations. Clin Pharmacokinet 1996; 30: 300-313.
25. Toon S, Holt BL, Mullins FG, et al. Investigations into the potential effects of multiple dose ketorolac on the pharmacokinetics and pharmacodynamics of racemic warfarin. Br J Clin Pharmacol 1990; 30: 743-750.
26. Kelly JG, O'Malley K. Clinical pharmacokinetics of oral anticoagulants. Clin Pharmacokinet 1979; 4: 1-15.
27. O'Reilly RA. Studies on the optical enantiomorphs of warfarin in man. Clin Pharmacol Ther 1974; 16: 348-354.
28. Yacobi A, Masson E, Moros D, et al. Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin. J Clin Pharmacol 2000; 40: 826-835.
29. Kong AN, Tomasko L, Waldman SA, et al. Losartan does not affect the pharmacokinetics and pharmacodynamics of warfarin. J Clin Pharmacol 1995; 35: 1008-1015.
30. King SY, Joslin MA, Raudibaugh K, et al. Dose-dependent pharmacokinetics of warfarin in healthy volunteers. Pharm Res 1995; 12: 1874-1877.