INVESTIGATION INTO THE BIOEQUIVALENCE OF A NEW ALLOPURINOL TABLET FORMULATION COMPARED WITH A STANDARD PREPARATION

An investigation of the bioequivalence of a new allopurinol formulatio n with 300 mg. allopurinol (GAS 315-30-0, allo 300 von ct) was perform ed in a two-way cross-over study with 18 subjects. The relative bioava ilability with respect to a reference preparation for AUC related to o xipurinol was 98.1% and for C-max 91.7%. A positive decision for bioeq uivalence derived from the usual confidence intervals for both paramet ers related to allopurinol and the metabolite oxipurinol. respectively , t(max) showed no difference regarding oxipurinol. The new formulatio n was bioequivalent to the reference.