Pharmacokinetic and bioequivalence of two formulations of Valsartan/Amlodipine Tablet(I) in healthy Chinese volunteers: A randomized, three-period, partially replicated crossover study

Valsartan/amlodipine fixed-dose combination tablets provide synergistic blood pressure control by combining complementary mechanisms of action. This publication reports a randomized, open-label, three-period, partially replicated crossover bioequivalence study of a new generic Valsartan/Amlodipine Tablet(I) versus the reference product in 72 healthy Chinese volunteers under fasting and fed conditions, with valsartan and amlodipine plasma concentrations measured by LC-MS/MS and pharmacokinetic parameters derived using Phoenix WinNonlin. The test and reference formulations were shown to be bioequivalent, with no suspected serious adverse reactions or events reported during the trial. These results support the launch of the new generic combination product in China and offer methodological insights applicable to bioequivalence trials of similar fixed-dose antihypertensive combinations.