Investigation of the bioequivalence of a new amitriptyline tablet formulation compared with a standard preparation

An investigation of the bioequivalence of a new tablet formulation (amitrip tylin 25 von ct) with 28.3 mg amitriptyline hydrochloride (CAS 549-18-8) wa s performed in a two-way crossover study with 18 subjects. The relative bio availability with respect to a reference preparation for AUC related to ami triptyline (CAS 50-48-6) was 99.3 % and for C-max 100.4 %. A positive decis ion for bioequivalence derived from the usual confidence intervals for both parameters related to amitriptyline and the metabolite nortriptyline (CAS 72-69-5), respectively. t(max) showed no difference. The new formulation wa s bioequivalent to the reference.