Editor-in-Chief İlkay Küçükgüzel Associate Editor Aslı Türe Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal 2011 , Vol 15 , Issue 3
Bioequivalence Studies in Healthy Volunteers: Olmesartan Medoxomil
Latif Özbay1,2, Z. İrem Diler1, Durişehvar Özer Ünal1,2, Dilek Erol1,2
1Yeditepe Üniversitesi , İKU Kliniği/İLU Laboratuvarı, İstanbul, Türkiye
2Yeditepe Üniversitesi, Eczacılık Fakültesi, İstanbul, Türkiye
DOI : 10.12991/201115428 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. Keywords : Bioequivalence, olmesartan medoxomil, healthy volunteers, LC-MS/MS
Marmara University