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 Cmax 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 after single-dose administration. 90% CI of geometric mean ratios (GMRs) of AUC0-t, AUC0-∞, and Cmax of telmisartan and hydrochlorothiazide of two FDC formulations fell within the predefined bioequivalence range of 80.0%-125.0% under both fasted and fed conditions. Administration with food had significant effects on telmisartan pharmacokinetic parameters but a slight impact on hydrochlorothiazide. Notably, Cmax and AUC of telmisartan were significantly decreased by 39.6%-43.7% in the fed versus fasted conditions. Safety assessments revealed all treatments were safe and well tolerated. Two telmisartan-hydrochlorothiazide FDC formulations were bioequivalent in healthy Chinese subjects in both fasted and fed states. All treatments were well tolerated.
Keywords: bioequivalence; fixed‐dose combination (FDC); hydrochlorothiazide; pharmacokinetics; telmisartan.
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