Abstract

The study was carried out in healthy Chilean volunteers in order to compare the pharmacokinetics (rate and extentabsorption) of two commercial oral formul ations of 50 mg hydrochlorothiazide. Thirty nine subjects were administeredhydrochlorothiazide tablets of test (T) and reference (R) formulation in a single blind, randomized, fasting, 2 × 2 crossover study, sevenwashout days. Blood samples were taken during a 48 h period after drug administration. Plasma concentrations were quantified byHPLC-MS/MS. The primary parameters log–transformed Cmax (maximum plasma concentration), AUC0-t and AUC0-∞ (area under theplasma concentration-time curve from zero to the last time and zero to infinity) were tested for bioequivalence considering the ratios ofgeometric means (test/reference); whereas tmax (the time of maximum plasma concentration) was analyzed nonparametrically. The 90%confidence intervals for the geometric mean values of test/reference ratios for Cmax, AUC0-t and AUC0-∞ were 95.37%, 93.59% and96.34%, respectively, and were located within the bioequivalence acceptance range of 80~125%, as were tmax and elimination constants.Together, we conclude that the test formulation of the hydrochlorothiazide 50 mg tablet is bioequivalent to the reference product andsuitable for generic prescription (18) (PDF) Bioequivalence Study of Two Hydrochlorothiazide Formulations after Oral Administration in Healthy Chilean Volunteers. Available from: https://www.researchgate.net/publication/312249521_Bioequivalence_Study_of_Two_Hydrochlorothiazide_Formulations_after_Oral_Administration_in_Healthy_Chilean_Volunteers [accessed Sep 12 2022].