The Bioequivalence Between Valsartan Oral Solution and Suspension Formulations Developed for Pediatric Use

Abstract

The bioequivalence of valsartan 160 mg oral solution compared to suspension was assessed in a single‐dose, open‐label, randomized, 2‐period, 2‐way crossover study in 82 healthy adults. The participants were randomly assigned (1:1) to receive a single dose of the solution or suspension formulation in each of the two treatment periods. Serial blood samples for pharmacokinetic evaluation were collected up to 48 hours post‐dose. The pharmacokinetic parameters were estimated by noncompartmental methods and analyzed as per bioequivalence criteria of statistical analysis. The peak plasma concentration of valsartan was reached with median time of 1 and 3 hours with solution and suspension formulation, respectively. Compared to suspension formulation, the mean peak plasma concentration with solution formulation was higher by 32% (90%CI, 1.27‐1.38) while the geometric mean ratios (1.09) and the associated 90%CIs (1.05‐1.13) of both the areas under the concentration time‐curves (from time zero to the last quantifiable concentration and from time zero to infinity) were contained in the required range of 0.80 to 1.25. No new safety signals were observed with either of the formulations.

Bioequivalência de duas formulações de Valsartana 320mg comprimido revestido em participantes sadios de ambos os sexos em condição de jejum

“…A Figura 1 apresenta as curvas médias das concentrações plasmáticas de valsartana de cada coleta (medicamentos referência e teste) versus tempo, considerando as amostras dos 59 voluntários que finalizaram o estudo. anteriormente em diversos estudos publicados, tendo atingido os mesmos objetivos em relação ao desempenho 1,5,[8][9][10][11][12][13][14][15][16] .…”