Alejandro Saúl Padrón Yaquis
Center for Drug Research and Development, Cuba
Title: Bioequivalence of two prolonged release diclofenac sodium formulations in healthy volunteers
Biography
Biography: Alejandro Saúl Padrón Yaquis
Abstract
Introduction: The implementation of generic drug development programs constitutes a basic component of global health policy. The aim of this work is to determine the existence of bioequivalence between two prolonged release diclofenac sodium formulations in healthy volunteers.
Materials and methods: A phase I, randomized, crossover, double-blind clinical trial was conducted where Voltaren Retard® (Novartis, Switzerland) and a prolonged release Cuban diclofenac sodium formulation (CIDEM, Havana, Cuba) were compared. The sampling period was 40 hours, with a washout time of 15 days between each period. Thirty-six healthy volunteers of both sexes, aged between 18 and 50, were included. All subjects received orally a single dose of 100 mg (one tablet) of the corresponding formulation in each period.
Results: The quantification of diclofenac sodium in plasma by HPLC demonstrated that both formulations could be considered as bioequivalent. Mean values of the key pharmacokinetic parameters were: AUC (4924.25 vs. 4928.32 μg/mL), Cmax (1046.97 vs. 1042.19 μg/mL); median Tmax was 2 hours for both formulations. The confidence intervals for AUC and Cmax were 98.3-101.7 and 98.75-101.2, respectively. The most frequent adverse events, with both formulations, were headache (11.1%), increase in transaminases values (11.1%), increase in urea (11.1%) and hypertension (8.3%), all of them mild.
Conclusions: Cuban prolonged release diclofenac sodium formulation was bioequivalent with the international leader formulation Voltaren Retard®.