Журнал биоэквивалентности и биодоступности

Абстрактный

Bioequivalence Study of Two Valsartan 160 mg Formulations: An Open- Label, Randomised-Sequence, Single-Dose, Two-Way Crossover Study in Healthy Volunteers under Fasting Conditions

Wen Yao Mak, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay Yuen

The aim of the study was to evaluate the rate and extent of absorption of a local generic valsartan formulation against that of the innovator product (reference formulation) in order to establish bioequivalence between both products. The study was an open-label, randomised-sequence, single-dose, two-way crossover study in 24 healthy volunteers under fasting conditions. The washout period was set at 7 days between the two treatment periods. Blood samples were collected up till 24-hour post dose. Plasma level of valsartan was determined by high performance liquid chromatography with fluorescence detector. Non-compartmental model was used to analyse the pharmacokinetic parameters, which included Tmax, Cmax, AUC0-t, AUC0-∞, t1/2 and ke. Analysis of variance (ANOVA) was used to analyse values of Cmax, AUC0-t, AUC0-∞, and ke, while Wilcoxon Signed Rank Test for paired samples was used to analyse Tmax. Tolerability of the test formulation was assessed throughout the study. All parameter assessed were found to be within the acceptable limit of 80.00% to 125.00%. No adverse event was reported. In conclusion, the test formulation was bioequivalent to the reference formulation, based on the rate and extent of absorption of both products.