Özbay, Latif Yeditepe Üniversitesi - Eczacilik Fakültesi, IKU Klinigi - ILU Laboratuvari, Turkey , Diler, Z. Irem Yeditepe Üniversitesi - IKU Klinigi - ILU Laboratuvari, Turkey , Ünal, Durisehvar Özer Yeditepe Üniversitesi - Eczacilik Fakültesi, IKU Klinigi - ILU Laboratuvari, Turkey , Erol, Dilek Yeditepe Üniversitesi - Eczacilik Fakültesi, IKU Klinigi - ILU Laboratuvari, Turkey

Bioequivalence Studies in Healthy Volunteers: Olmesartan Medoxomil

18715

This study aimed to investigate the bioequivalence of test and reference formulations of 40mg olmesartan medoxomil (CAS 144689-63-4) in 36 healthy male volunteers. Olmesartan medoxomil is an angiotensin II receptor antagonist used to treat high blood pressure. Volunteers were treated with two formulations of 40mg olmesartan medoxomil according to a fasting, randomised, open-label, crossover, single dose, two-period bioequivalence study design with a 14 days wash-out period. Blood samples were taken up to 72 h post-dose, the plasma concentrations of olmesartan medoxomil were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). AUC0-∞, AUC0-last, Cmax and Tmax were calculated for both formulations. The parametric 90 % confidence intervals for the primary target parameters were between 90.73-102.34 for AUC0-last, 91.13-102.47 for AUC0-∞ and between 90.17- 102.85 for Cmax. The acceptance ranges prospectively defined in the protocol for this trial were fulfilled. Based on the available information it was determined between the bioequivalence acceptance range (80-125%). This single dose study found that the test and the reference products met the regulatory criteria for bioequivalence in these fasting healthy male volunteers.

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Bioequivalence , olmesartan medoxomil , healthy volunteers , LC , MS , MS

Journal of Research in Pharmacy

128