Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. single oral dose administrated to each volunteer. Metho...

Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap ® and Mikardis was conducted with 60 volunteers. Aim. The purpose the trial comparative pharmacokinetics evidence (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, ...

PURPOSE The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. MATERIALS AND METHODS A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study peri...

PURPOSE The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of bioequivalence. In this study, both visual and chromametric assessments have been carried out on two topical creams containing clobetasol propionate (0.05%) and the results from both methods are ...

PURPOSE Investigate the role of metabolites in bioequivalence (BE) assessment. METHODS. Sets of ordinary differential equations are used to generate concentration - time data for both parent drug (P) and metabolite (M). The calculations include 24 subjects, two different formulations (Test, Reference), and a range of Test/Reference ratios for the fraction of dose absorbed and the rate of absorp...