Acceso abierto

Comparative bioavailability of two oral formulations of clopidogrel: Determination of clopidogrel and its carboxylic acid metabolite (SR26334) under fasting and fed conditions in healthy subjects


Cite

1. P. Savi, C. Labouret, N. Delesque, F. Guette, J. Lupker and J. M. Herbert, P2Y12, a new platelet ADP receptor, target of clopidogrel, Biochem. Biophys. Res. Commun. 283 (2001) 379-383; DOI: 10.1006/bbrc.2001.4816.10.1006/bbrc.2001.481611327712Search in Google Scholar

2. CAPRIE Steering Committee, A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE), Lancet 348 (1996) 1329-1339; DOI: 10.1016/ S0140-6736(96)09457-3. Available online 10 January 2000.Search in Google Scholar

3. L. Bonello, U. S. Tantry, R. Marcucci, R. Blindt, D. J. Angiolillo, R. Becker, D. L. Bhatt, M. Cattaneo, J. P. Collet, T. Cuisset, C. Gachet, G. Montalescot, L. K. Jennings, D. Kereiakes, D. Sibbing, D. Trenk, J. W. Van Werkum, F. Paganelli, M. J. Price, R. Waksman and P. A. Gurbel, Consensus and future directions on the definition of high on-treatment platelet reactivity to adenosine diphosphate, J. Am. Coll. Cardiol. 56 (2010) 919-933; DOI: 10.1016/j.jacc.2010.04.047.10.1016/j.jacc.2010.04.04720828644Search in Google Scholar

4. A. L. Frelinger III, D. L. Bhatt, R. D. Lee, D. J. Mulford, J. Wu , S. Nudurupati, A. Nigam, M. Lampa, J. K. Brooks, M. R. Barnard and A. D. Michelson, Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function, J. Am. Coll. Cardiol. 26 (2013) 872-879; DOI: 10.1016/j.jacc.2012.11.040.10.1016/j.jacc.2012.11.04023333143Search in Google Scholar

5. P. Savi, J. M. Pereillo, M. F. Uzabiaga, J. Combalbert, C. Picard, J. P. Maffrand, M. Pascal and J. M. Herbert, Identification and biological activity of the active metabolite of clopidogrel, Thromb. Haemost. 84 (2000) 891-986.10.1055/s-0037-1614133Search in Google Scholar

6. T. A. Clarke and L. A. Waskell, The metabolism of clopidogrel is catalyzed by human cytochrome P450 3A and is inhibited by atorvastatin, Drug Metab. Dispos. 31 (2003) 53-59; DOI: 10.1124/ dmd.31.1.53.10.1124/dmd.31.1.5312485953Search in Google Scholar

7. P. Savi, J. Combalbert, C. Gaich, M. C. Rouchon, J. P. Maffrand, Y. Berger and J. M. Herbert, The antiaggregating activity of clopidogrel is due to a metabolic activation by the hepatic cytochrome P450-1A, Thromb. Haemost. 72 (1994) 313-317.10.1055/s-0038-1648859Search in Google Scholar

8. H. Caplain, F. Donat, C. Gaud and J. Necciari, Pharmacokinetics of clopidogrel, Semin. Thromb. Hemost. 25 (1999) 25-28.Search in Google Scholar

9. J. McEwen, G. Strauch, P. Perles, G. Pritchard, T. E. Moreland, J. Necciari and J. P. Dickinson, Clopidogrel bioavailability: absence of influence of food or antacids, Semin. Thromb. Hemost. 25 (1999) 47-50.Search in Google Scholar

10. R. V. Nirogi, V. N. Kandikere and K. Mudigonda, Effect of food on bioavailability of a single oral dose of clopidogrel in healthy male subjects, Arzneimittelforsch. 56 (2006) 735-739; DOI: 10.1055/s-0031-1296783.10.1055/s-0031-129678317220050Search in Google Scholar

11. F. Hurbin, X. Boulenc, N. Daskalakis, C. Farenc, T. Taylor, D. Bonneau, F. Lacreta, S. Cheng and E. Sultan, Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men, Clin. Pharmacol. 52 (2012) 1506-1515; DOI: 10.1177 /0091270011419852.Search in Google Scholar

12. European Medicines Agency, Committee for Proprietary Medicinal Products (CPMP), ICH Topic E6 (R1), Guideline for good clinical practice, Step 5, Note for guidance on good clinical practice, CPMP/ICH/135/95, July 2002; http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000429.jsp&mid=WC0b01ac0580029590; access date April 22, 2013.Search in Google Scholar

13. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Off. J. Eur. Communities L Legis. L121 (2001) 34-44; http://ec.europa.eu/ health/documents/eudralex/vol-1/; access date April 22, 2013.Search in Google Scholar

14. Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Off. J. Eur. Communities L Legis. L159 (2003) 46-94; http://ec.europa.eu/health/documents/eudralex/vol-1/; access date April 22, 2013.Search in Google Scholar

15. World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, October 2008; http://www.wma.net/ en/30publications/10policies/b3/; access date April 22, 2013.Search in Google Scholar

16. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry, Bioanalytical Method Validation, May 2001; www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf; access date April 22, 2013.Search in Google Scholar

17. D. Taubert, A. Kastrati, S. Harlfinger, O. Gorchakova, A. Lazar, N. von Beckerath, A. Schömig and E. Schömig, Pharmacokinetics of clopidogrel after administration of a high loading dose, Thromb. Haemost. 92 (2004) 311-316; DOI: 10.1160/TH04-02-0105.10.1160/TH04-02-010515269827Search in Google Scholar

18. N. von Beckerath, D. Taubert, G. Pogatsa-Murray, E. Schömig, A. Kastrati and A. Schömig, Absorption, metabolization, and antiplatelet effects of 300-, 600-, and 900-mg loading doses of clopidogrel, results of the ISAR-CHOICE (Intracoronary Stenting and Antithrombotic Regimen: Choose Between 3 High Oral Doses for Immediate Clopidogrel Effect) Trial, Circulation 112 (2005) 2946-2950; DOI: 10.1161/?CIRCULATIONAHA.105.559088.Search in Google Scholar

19. D. Taubert, N. von Beckerath, G. Grimberg, A. Lazar, N. Jung, T. Goeser, A. Kastrati, A. Schömig and E. Schömig, Impact of P-glycoprotein on clopidogrel absorption, Clin. Pharmacol. Ther. 80 (2006) 486-501; DOI: 10.1016/j.clpt.2006.07.007.10.1016/j.clpt.2006.07.00717112805Search in Google Scholar

20. A. R. Shuldiner, J. R.O’Connell, K. P. Bliden, A. Gandhi, K. Ryan, R. B. Horenstein, C. M. Damcott, R. Pakyz, U. S. Tantry, Q. Gibson, T. I. Pollin, W. Post, A. Parsa, B. D. Mitchell, N. Faraday W. Herzog and P. A. Gurbel, Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy, JAMA. 26 (2009) 849-857; DOI: 10.1001/ jama.2009.1232.10.1001/jama.2009.1232364156919706858Search in Google Scholar

21. J. L. Mega, S. L. Close, S. D. Wiviott, L. Shen, J. R. Walker, T. Simon, E. M. Antman, E. Braunwald and M. S. Sabatine, Genetic variants in ABCB1 and CYP2C19 and cardiovascular outcomes after treatment with clopidogrel and prasugrel in the TRITON-TIMI 38 trial: a pharmacogenetic analysis, Lancet 376 (2010) 1312-1319; DOI: 10.1016/S0140-6736(10)61273-1.10.1016/S0140-6736(10)61273-1Search in Google Scholar

22. T. Simon, C. Verstuyft,M.Mary-Krause, L. Quteineh, E. Drouet,N.Méneveau, P. G. Steg, J. Ferrières, N. Danchin and L. Becquemont, Genetic determinants of response to clopidogrel and cardiovascular events, N. Engl. J. Med. 360 (2009) 363-375; DOI: 10.1056/NEJMoa0808227.10.1056/NEJMoa080822719106083Search in Google Scholar

23. W. C. Lau, L. A. Waskell, P. B. Watkins, C. J. Neer, K. Horowitz, A. S. Hopp, A. R. Tait, D. G. Carville, K. E. Guyer and E. R. Bates, Atorvastatin reduces the ability of clopidogrel to inhibit platelet aggregation: a new drug-drug interaction, Circulation 107 (2003) 32-37; DOI: 10.1161/ ?01.CIR.0000047060.60595.CC.Search in Google Scholar

24. W. C. Lau, P. A. Gurbel, P. B. Watkins, C. J. Neer, A. S. Hopp, D. G. Carville, K. E. Guyer, A. R. Tait and E. R. Bates, Contribution of hepatic cytochrome P450 3A4 metabolic activity to the phenomenon of clopidogrel resistance, Circulation 109 (2004) 166-171; DOI: 10.1161/01.CIR. 0000112378.09325.F9.Search in Google Scholar

25. European Medicines Agency, Committee for Human Medicinal Products (CHMP), Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party, EMA/618604/2008 Rev. 7, February 2013; http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000370.jsp&mid=WC0b01ac0580032ec5; access date April 22, 2013. Search in Google Scholar

eISSN:
1846-9558
ISSN:
1330-0075
Idioma:
Inglés
Calendario de la edición:
4 veces al año
Temas de la revista:
Pharmacy, other