Effect of High-Fat Meal on the Pharmacokinetics and Safety of Valsartan/Amlodipine Fixed Dose Combination Tablets in Healthy Subjects

References

• Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016;387(10022):957–967. doi:10.1016/S0140-6736(15)01225-8
   PubMed Web of Science ®Google Scholar
• Mallat SG, Itani HS, Tanios BY. Current perspectives on combination therapy in the management of hypertension. Integr Blood Press Control. 2013;17:69–78. doi:10.2147/IBPC.S33985
   Google Scholar
• Gu Q, Burt VL, Dillon CF, et al. Trends in antihypertensive medication use and blood pressure control among United States adults with hypertension: the National Health And Nutrition Examination Survey, 2001 to 2010. Circulation. 2012;126(17):2105–2114. doi:10.1161/CIRCULATIONAHA.112.096156
   PubMed Web of Science ®Google Scholar
• James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–520. doi:10.1001/jama.2013.284427
   PubMed Web of Science ®Google Scholar
• Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureThe JNC 7 Report. JAMA. 2003;289(19):2560–2572. doi:10.1001/jama.289.19.2560
   PubMed Web of Science ®Google Scholar
• Murdoch D, Heel RC. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease. Drugs. 1991;41(3):478–505. doi:10.2165/00003495-199141030-00009
   PubMed Web of Science ®Google Scholar
• Markham A, Goa KL. A review of its pharmacology and therapeutic use in essential hypertension. Drugs. 1997;54(2):299–311. doi:10.2165/00003495-199754020-00009
   PubMed Web of Science ®Google Scholar
• Meyer MC, Whyatt PL. Hydrochlorothiazide. J Am Pharm Assoc. 1976;16(1):47–50.
   PubMedGoogle Scholar
• Sever PS, Franz HM. Hypertension management 2011: optimal combination therapy. Eur Heart J. 2011;32(20):2499–2506. doi:10.1093/eurheartj/ehr177
   PubMed Web of Science ®Google Scholar
• Novartis Pharmaceuticals Corporation. EXFORGE^®(Amlodipine Besylate/Valsartan) Tablets [Prescribing Information]. Switzerland: Novartis Pharmaceuticals Corporation; 2021.
   Google Scholar
• Melander A. Influence of food on the bioavailability of drugs. Clin Pharmacokinet. 1978;3(5):337–351. doi:10.2165/00003088-197803050-00001
   PubMed Web of Science ®Google Scholar
• Yu LX, Straughn AB, Faustino PJ, et al. The effect of food on the relative bioavailability of rapidly dissolving immediate-release solid oral products containing highly soluble drugs. Mol Pharm. 2004;1(5):357–362. doi:10.1021/mp0499407
   PubMed Web of Science ®Google Scholar
• Marasanapalle VP, Crison JR, Ma J, Li X, Jasti BR. Investigation of some factors contributing to negative food effects. Biopharm Drug Dispos. 2009;30(2):71–80. doi:10.1002/bdd.647
   PubMed Web of Science ®Google Scholar
• Faulkner JK, Hayden ML, Chasseaud LF, Taylor T. Absorption of amlodipine unaffected by food. Solid dose equivalent to solution dose. Arzneimittelforschung. 1989;39(7):799–801.
   PubMed Web of Science ®Google Scholar
• Chung M, Calcagni A, Glue P, Bramson C. Effect of food on the bioavailability of amlodipine besylate/atorvastatin calcium combination tablet. J Clin Pharmacol. 2006;46(10):1212–1216. doi:10.1177/0091270006291097
   PubMed Web of Science ®Google Scholar
• Williams RL, Mordenti J, Upton RA, et al. Effects of formulation and food on the absorption of hydrochlorothiazide and triamterene or amiloride from combination diuretic products. Pharm Res. 1987;4(4):348–352. doi:10.1023/a:1016409606936
   PubMed Web of Science ®Google Scholar
• Israili ZH. Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension. J Hum Hypertens. 2000;14(S1):S73–S86. doi:10.1038/sj.jhh.1000991
   PubMedGoogle Scholar
• Sunkara G, Jiang X, Reynolds C, et al. Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects. Clin Pharmacol Drug Dev. 2014;3(6):487–492. doi:10.1002/cpdd.131
   PubMed Web of Science ®Google Scholar
• Wang T, Wang Y, Lin S, et al. Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: bioequivalence Study Findings. J Clin Lab Anal. 2020;34(6):e23228. doi:10.1002/jcla.23228
   PubMed Web of Science ®Google Scholar
• Wu Q, Wang X, Chen Q, et al. Pharmacokinetics and Bioequivalence of Two Formulations of Valsartan 80 mg Capsules: a Randomized, Single Dose, 4-Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2020;14:4221–4230. doi:10.2147/DDDT.S253078
   PubMed Web of Science ®Google Scholar
• Novartis Pharmaceuticals Corporation. Diovan^® (Valsartan) Tablets [Prescribing Information]. Switzerland: Novartis Pharmaceuticals Corporation; 2017.
   Google Scholar
• Ayalasomayajula S, Langenickel TH, Chandra P, et al. Effect of food on the oral bioavailability of the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan (LCZ696) in healthy subjects. Int J Clin Pharmacol Ther. 2016;54(12):1012–1018. doi:10.5414/CP202604
   PubMed Web of Science ®Google Scholar
• Akahori M, Ayalasomayajula S, Langenickel T, et al. Pharmacokinetics After Single Ascending Dose, Food Effect, and Safety of Sacubitril/Valsartan (LCZ696), an Angiotensin Receptor and Neprilysin Inhibitor, in Healthy Japanese Subjects. Eur J Drug Metab Pharmacokinet. 2017;42(3):407–416. doi:10.1007/s13318-016-0354-1
   PubMed Web of Science ®Google Scholar
• Deng J, Zhu X, Chen Z, et al. A review of food drug interactions on oral drug absorption. Drugs. 2017;77(17):1833–1855. doi:10.1007/s40265-017-0832-z
   PubMed Web of Science ®Google Scholar