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Bioequivalence Study of Two Hydrochlorothiazide Formulations after Oral Administration in Healthy Chilean Volunteers




Author(s)

Fierro Humberto, Rojas Romina, Yáñez Sebastian, Acuña Paola, Rosales Katherine, Yevenes Paulina, Yzoard Marcia, Tapia Claudia, Rivas Violeta, Caba Alvaro, Copaja Miguel and Jorge Fuentealba

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DOI:10.17265/2328-2150/2016.12.004

The study was carried out in healthy Chilean volunteers in order to compare the pharmacokinetics (rate and extent absorption) of two commercial oral formulations of 50 mg hydrochlorothiazide. Thirty nine subjects were administered hydrochlorothiazide tablets of test (T) and reference (R) formulation in a single blind, randomized, fasting, 2 × 2 crossover study, seven washout days. Blood samples were taken during a 48 h period after drug administration. Plasma concentrations were quantified by HPLC-MS/MS. The primary parameters log–transformed C_max (maximum plasma concentration), AUC_0-t and AUC_0-∞ (area under the plasma concentration-time curve from zero to the last time and zero to infinity) were tested for bioequivalence considering the ratios of geometric 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 C_max, AUC_0-t and AUC_0-∞ were 95.37%, 93.59% and 96.34%, 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 and suitable for generic prescription.

Bioequivalence, hydrochlorothiazide, interchangeable.

Humberto, F., et al. 2016. “Bioequivalence Study of Two Hydrochlorothiazide Formulations after Oral Administration in Healthy Chilean Volunteers.” Journal of Pharmacy and Pharmacology 4 (12): 679-685.