Pharmacokinetic and Bioequivalence Evaluation of Two Lercanidipine Hydrochloride Tablets in Healthy Chinese Volunteers.

Lercanidipine hydrochloride is a third-generation dihydropyridine calcium channel blocker used to treat mild-to-moderate hypertension. The aim of this study is to compare the pharmacokinetic characteristics of lercanidipine hydrochloride tablets (10 mg) in healthy Chinese volunteers after oral administration under fasting conditions with those of a reference formulation, and to evaluate the bioequivalence and safety of the two formulations. A validated liquid chromatography-tandem mass spectrometry method was established to determine the plasma concentration of lercanidipine. Phoenix WinNonlin software (version 7.0) was used to calculate pharmacokinetic parameters based on plasma drug concentration-time data. The geometric mean ratios and 90% confidence intervals of Cmax, AUC0-t, and AUC0-∞ for the test formulation relative to the reference formulation were 110.37% (99.96%-121.86%), 106.81% (99.65%-114.49%), and 106.91% (99.86%-114.45%), respectively, all within the range of 80.00%-125.00%. The test formulation met the bioequivalence acceptance criteria and was well tolerated by healthy Chinese volunteers under fasting conditions.