Bioequivalence and Food Effect Assessment of Two Fixed-Dose Combination Formulations of Telmisartan-Hydrochlorothiazide Tablets in Chinese Healthy Subjects.

ABSTRACT: This study assessed the bioequivalence and food effect of two fixed-dose combination (FDC) formulations of telmisartan-hydrochlorothiazide tablets (telmisartan 40 mg, hydrochlorothiazide 12.5 mg) in healthy Chinese subjects. Seventy-two subjects were enrolled and divided into fasted and fed cohorts in a single-center, randomized, open-label, single-dose, three-period, three-sequence, and crossover study. The pharmacokinetic characteristics of telmisartan and hydrochlorothiazide, including C_max and AUC, were compared after subjects received single oral doses of telmisartan-hydrochlorothiazide tablets using a validated LC-MS/MS method. Safety and tolerability of treatments were monitored. Pharmacokinetic profiles of two FDC telmisartan-hydrochlorothiazide tablets were comparable a

SUBMITTER: Hu M 

PROVIDER: S-EPMC12024483 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature