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

This publication evaluates the effect of a high-fat meal on the pharmacokinetics and safety of an 80/5 mg valsartan/amlodipine fixed-dose combination tablet in 88 healthy subjects, derived from a bioequivalence trial comparing fasted and fed administration. Plasma concentrations were measured by HPLC-MS and pharmacokinetic parameters calculated using Phoenix WinNonlin, including its bioequivalence module. A high-fat meal significantly reduced valsartan Cmax and AUC by 51-57%, falling outside the standard bioequivalence range versus fasted conditions, while amlodipine pharmacokinetics were unaffected by food; both treatments were safe and well tolerated. The results indicate that food meaningfully affects valsartan but not amlodipine pharmacokinetics within this fixed-dose combination.