Effect of steady-state ambrisentan on the pharmacokinetics of a single dose of the oral contraceptive norethindrone (norethisterone) 1mg/ethinylestradiol 35 lg in healthy subjects

Clinical Drug Investigation

Volumn 30, Issue 5, 2010, Pages 313-324

  Spence, Rebecca ^a   Mandagere, Arun ^a   Walker, Gennyne ^a   Dufton, Christopher ^a   Boinpally, Ramesh ^a  

^a GILEAD SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMBRISENTAN; ANTIHYPERTENSIVE AGENT; ETHINYLESTRADIOL; NORETHISTERONE; ORAL CONTRACEPTIVE AGENT; PHENYLPROPIONIC ACID DERIVATIVE; PYRIDAZINE DERIVATIVE;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; FEMALE; HUMAN; MIDDLE AGED;

ADOLESCENT; ADULT; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; CONTRACEPTIVES, ORAL, COMBINED; ETHINYL ESTRADIOL; FEMALE; HUMANS; MIDDLE AGED; NORETHINDRONE; PHENYLPROPIONATES; PYRIDAZINES; YOUNG ADULT;

EID: 77953244099     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11534940-000000000-00000     Document Type: Article

References (21)

1. Rubin LJ. Primary pulmonary hypertension. N Engl J Med 1997; 336 (2): 111-7
2. Barst RJ, Rubin LJ, McGoon MD, et al. Survival in primary pulmonary hypertension with long-term continuous intravenous prostacyclin. Ann Intern Med 1994; 121 (6): 409-15
3. Bonnin M, Mercier FJ, Sitbon O, et al. Severe pulmonary hypertension during pregnancy: mode of delivery and anesthetic management of 15 consecutive cases. Anesthesiology 2005; 102 (6): 1133-7
4. Weiss BM, Hess OM. Pulmonary vascular disease and pregnancy: current controversies, management strategies, and perspectives. Eur Heart J 2000; 21 (2): 104-15
5. Weiss BM, Zemp L, Seifert B, et al. Outcome of pulmonary vascular disease in pregnancy: a systematic overview from 1978 through 1996. J Am Coll Cardiol 1998; 31 (7): 1650-7
6. Bedard E, Dimopoulos K, Gatzoulis MA. Has there been any progress made on pregnancy outcomes among women with pulmonary arterial hypertension? Eur Heart J 2009; 30 (3): 256-65
7. Treinen KA, Louden C, Dennis MJ, et al. Developmental toxicity and toxicokinetics of two endothelin receptor antagonists in rats and rabbits. Teratology 1999; 59 (1): 51-9
8. Shenfield GM, Griffin JM. Clinical pharmacokinetics of contraceptive steroids: an update. Clin Pharmacokinet 1991; 20 (1): 15-37
9. Shenfield GM. Oral contraceptives: are drug interactions of clinical significance? Drug Saf 1993; 9 (1): 21-37
10. van Giersbergen PL, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006; 44 (3): 113-8
11. Actelion Pharmaceuticals Ltd. Tracleer (bosentan) tablets. United States Food and Drug Administration Drug Product Label, 2009 [online]. Available from URL: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=Search.DrugDetails [Accessed 2010 Mar 1]
12. Pfizer Canada Inc. Thelin (sitaxsentan sodium) product monograph, 11-4-2008 [online]. Available from URL: http://www.pfizer.ca/english/ our%20products/prescription %20pharmaceuticals/default.asp?s=1 [Accessed 2010 Mar 1]
13. Gilead Sciences Inc. Food and Drug Administration [pharmacology review (part 1)] for original new drug application 22-081 [online]. Available from URL: http://www.fda.gov/cder/foi/nda/2007/022081s000TOC.htm [Accessed 2008 Nov 21]
14. Spence R, Mandagere A, Dufton C, et al. Pharmacokinetics and safety of ambrisentan in combination with sildenafil in healthy volunteers. J Clin Pharmacol 2008; 48 (12): 1451-9
15. Walker G, Mandagere A, Dufton C, et al. The pharmacokinetics and pharmacodynamics of warfarin in combination with ambrisentan in healthy volunteers. Br J Clin Pharmacol 2009; 67 (5): 527-34
16. Spence R, Harrison B, Mandagere A, et al. No clinical relevant pharmacokinetic interaction between ambrisentan and tadalafil. J Pharm Sciences 2009; 98 (12): 4962-74
17. Gilead Sciences. Letairis (ambrisentan) package insert. Foster City (CA): Gilead Sciences, 2008
18. FDA. Guidance for industry bioavailability and bioequivalence studies for orally administered drug products: general considerations, 2003 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceReg ulatoryInformation/Guidances/UCM070124.pdf [Accessed 2010 Mar 1]
19. Ortho-McNeil-Janssen Pharmaceuticals Inc. Ortho-Novum tablets. United States Food and Drug Administration Drug Product Label, 2006 [online]. Available from URL: http://www.ortho-mcneilpharmaceutical.com/ortho-mcneil pharmaceutical/about/product-index.html [Accessed 2010 Mar 1]
20. Fotherby K. Intrasubject variability in the pharmacokinetics of ethynyloestradiol. J Steroid Biochem Mol Biol 1991; 38 (6): 733-6
21. Hendrix CW, Jackson KA, Whitmore E, et al. The effect of isotretinoin on the pharmacokinetics and pharmacodynamics of ethinyl estradiol and norethindrone. Clin Pharmacol Ther 2004; 75 (5): 464-75