August 19, 2025Open Access

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

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Randomized trial confirms bioequivalence of Valsartan/Amlodipine tablets in healthy volunteers, suggesting safety for use.

The test formulation of valsartan/amlodipine was found to be bioequivalent to the reference formulation, ensuring effective treatment for hypertension.
Equivalence analysis used both the average bioequivalence and reference-scaled average bioequivalence methods, ensuring comprehensive results.
The study employed a validated LC-MS/MS method for pharmacokinetic analysis, focusing on accurate drug concentration measurement.
These findings support the market entry of a new generic valsartan/amlodipine tablet, potentially enhancing treatment options for patients.

Mei et al. (2025) studied this question.

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