Effect of grapefruit juice and food on the pharmacokinetics of pirfenidone in healthy Chinese volunteers: a diet–drug interaction study

References

• Adamali HI, Maher TM. (2012). Current and novel drug therapies for idiopathic pulmonary fibrosis. Drug Des Dev Ther 6:261–72
   PubMed Web of Science ®Google Scholar
• Azuma A, Nukiwa T, Tsuboi E, et al. (2005). Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 171:1040–7
   PubMed Web of Science ®Google Scholar
• Ballard TLP, Halaweish FT, Stevermer CL, et al. (2006). Naringin does not alter caffeine pharmacokinetics, energy expenditure, or cardiovascular haemodynamics in humans following caffeine consumption. Clin Exp Pharmacol Physiol 33:310–14
   PubMed Web of Science ®Google Scholar
• Bruss ML, Stanley SD, Margolin SB, et al. (2008). Pharmacokinetics and metabolism of intravenous pirfenidone in sheep. Biopharm Drug Dispos 29:119–26
   PubMed Web of Science ®Google Scholar
• Carter NJ. (2011). Pirfenidone: in idiopathic pulmonary fibrosis. Drugs 71:1721–32
   PubMed Web of Science ®Google Scholar
• Chakraborty S, Chopra P, Ambi SV, et al. (2014). Emerging therapeutic interventions for idiopathic pulmonary fibrosis. Expert Opin Investig Drugs 23:893–910
   PubMed Web of Science ®Google Scholar
• Ding X, Kaminsky LS. (2003). Human extrahepatic cytochromes P450: function in xenobiotic metabolism and tissue-selective chemical toxicity in the respiratory and gastrointestinal tracts. Annu Rev Pharmacol Toxicol 43:149–73
   PubMed Web of Science ®Google Scholar
• Dresser GK, Kim RB, Bailey DG. (2005). Effect of grapefruit juice volume on the reduction of fexofenadine bioavailability: possible role of organic anion transporting polypeptides. Clin Pharmacol Ther 77:170–7
   PubMed Web of Science ®Google Scholar
• EMA. (2015). InterMune. Esbriet(pirfenidone): EU summary of product characteristics. February 2011. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002154/WC500103049.pdf [last accessed 16 Jul 2015]
   Google Scholar
• Fuhr U, Klittich K, Staib AH. (1993). Inhibitory effect of grapefruit juice and its bitter principal, naringenin, on CYP1A2 dependent metabolism of caffeine in man. Br J Clin Pharmacol 35:431–6
   PubMed Web of Science ®Google Scholar
• Fuhr U, Maier A, Keller A, et al. (1995). Lacking effect of grapefruit juice on theophylline pharmacokinetics. Int J Clin Pharmacol Ther 33:311–14
   PubMed Web of Science ®Google Scholar
• Giri SN, Wang Q, Xie Y, et al. (2002). Pharmacokinetics and metabolism of a novel antifibrotic drug pirfenidone, in mice following intravenous administration. Biopharm Drug Dispos 23:203–11
   PubMed Web of Science ®Google Scholar
• Gupta MC, Garg SK, Badyal D, et al. (1999). Effect of grapefruit juice on the pharmacokinetics of theophylline in healthy male volunteers. Methods Find Exp Clin Pharmacol 21:679–82
   PubMed Web of Science ®Google Scholar
• Gurujeyalakshmi G, Hollinger MA, Giri SN. (1999). Pirfenidone inhibits PDGF isoforms in bleomycin hamster model of lung fibrosis at the translational level. Am J Physiol 276:L311–18
   PubMed Web of Science ®Google Scholar
• Hanley MJ, Cancalon P, Widmer WW, et al. (2011). The effect of grapefruit juice on drug disposition. Expert Opin Drug Metab Toxicol 7:267–86
   PubMed Web of Science ®Google Scholar
• Huang NY, Ding L, Wang J, et al. (2013). Pharmacokinetics, safety and tolerability of pirfenidone and its major metabolite after single and multiple oral doses in healthy Chinese subjects under fed conditions. Drug Res (Stuttg) 63:388–95
   PubMedGoogle Scholar
• Inomata M, Kamio K, Azuma A, et al. (2014). Pirfenidone inhibits fibrocyte accumulation in the lungs in bleomycin-induced murine pulmonary fibrosis. Respir Res 15:16–29
   PubMed Web of Science ®Google Scholar
• Jones MG, Fletcher S, Richeldi L. (2013). Idiopathic pulmonary fibrosis: recent trials and current drug therapy. Respiration 86:353–63
   PubMed Web of Science ®Google Scholar
• Kreuter M. (2014). Pirfenidone: an update on clinical trial data and insights from everyday practice. Eur Respir Rev 23:111–17
   PubMedGoogle Scholar
• Lane HY, Jann MW, Chang YC, et al. (2001). Repeated ingestion of grapefruit juice does not alter clozapine's steady-state plasma levels, effectiveness, and tolerability. J Clin Psychiatry 62:812–17
   PubMed Web of Science ®Google Scholar
• Lilja JJ, Backman JT, Laitila J, et al. (2003). Itraconazole increases but grapefruit juice greatlydecreases plasma concentrations of celiprolol. Clin Pharmacol Ther 73:192–8
   PubMed Web of Science ®Google Scholar
• Maish WA, Hampton EM, Whitsett TL, et al. (1996). Influence of grapefruit juice on caffeine pharmacokinetics and pharmacodynamics. Pharmacotherapy 16:1046–52
   PubMed Web of Science ®Google Scholar
• Nathan SD, Shlobin OA, Weir N, et al. (2011). Long-term course and prognosis of idiopathic pulmonary fibrosis in the new millennium. Chest 140:221–9
   PubMed Web of Science ®Google Scholar
• Noble PW, Albera C, Bradford WZ, et al. (2011). Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet 377:1760–9
   PubMed Web of Science ®Google Scholar
• Oku H, Shimizu T, Kawabata T, et al. (2008). Antifibrotic action of pirfenidone and prednisolone: different effects on pulmonary cytokines and growth factors in bleomycin-induced murine pulmonary fibrosis. Eur J Pharmacol 590:400–8
   PubMed Web of Science ®Google Scholar
• Ozdemir V, Kalow W, Okey AB, et al. (2001). Treatment-resistance to clozapine in association with ultrarapid CYP1A2 activity and the C-> A polymorphism in intron 1 of the CYP1A2 gene: effect of grapefruit juice and low-dose fluvoxamine. J Clin Psychopharmacol 21:603–7
   PubMed Web of Science ®Google Scholar
• Rubino CM, Bhavnani SM, Ambrose PG, et al. (2009). Effect of food and antacids on the pharmacokinetics of pirfenidone in older healthy adults. Pulm Pharmacol Ther 22:279–85
   PubMed Web of Science ®Google Scholar
• Schaefer CJ, Ruhrmund DW, Pan L, et al. (2011). Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev 20:85–97
   PubMedGoogle Scholar
• Schwarz UI, Seemann D, Oertel R, et al. (2005). Grapefruit juice ingestion significantly reduces talinolol bioavailability. Clin Pharmacol Ther 77:291–301
   PubMed Web of Science ®Google Scholar
• Seden K, Dickinson L, Khoo S, Back D. (2010). Grapefruit–drug interactions. Drugs 70:2373–407
   PubMed Web of Science ®Google Scholar
• Shi S, Wu J, Chen H, et al. (2007). Single-and multiple-dose pharmacokinetics of pirfenidone, an antifibrotic agent, in healthy Chinese volunteers. J Clin Pharmacol 47:1268–76
   PubMed Web of Science ®Google Scholar
• Tapaninen T, Neuvonen PJ, Niemi M. (2010). Grapefruit juice greatly reduces the plasma concentrations of the OATP2B1 and CYP3A4 substrate aliskiren. Clin Pharmacol Ther 88:339–42
   PubMed Web of Science ®Google Scholar
• Wanwimolruk S, Marquez PV. (2006). Variations in content of active ingredients causing drug interactions in grapefruit juice products sold in California. Drug Metab Drug Interact 21:233–43
   PubMedGoogle Scholar
• Wen YG, Liu X, He XL, et al. (2014). Simultaneous determination of pirfenidone and its metabolite in human plasma by liquid chromatography-tandem mass spectrometry: application to a pharmacokinetic study. J Anal Toxicol 38:645–52
   PubMed Web of Science ®Google Scholar
• USFDA. (2002). United States Food and Drug Administration Guidance for Industry, Food-effect bioavailability and fedbioequivalence studies. December 2002. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf [last accessed 16 Jul 2015]
   Google Scholar