TY - JOUR AU - Almeida, Susana; Filipe, Augusto; Vallée, François; Tanguay, Mario; Larouche, Richard; Lainesse, Audrey TI - Comparative Bioavailability of Two Formulations of Terbinafine T2 - Data from a cross-over, randomised, open-label bioequivalence study in healthy volunteers SN - 0004-4172 SN - 1616-7066 PY - 2004 JO - Arzneimittelforschung JF - Arzneimittelforschung LA - EN VL - 54 IS - 11 SP - 757 EP - 762 DA - 2011/12/24 KW - Antifungal agent KW - CAS 78628-80-5 KW - Terbinafine, bioavailability, bioequivalence, clinical pharmacokinetics, gender AB - An open-label, randomised, cross-over single dose study, using 2 periods × 2 sequences, with a minimum washout period of 21 days, was conducted in order to assess the comparative bioavailability of two formulations of terbinafine (CAS 78628-80-5) 250 mg tablets. Plasma samples were obtained at baseline, +0.333; 0.667; 1.00; 1.33; 1.67; 2.00; 2.33; 2.67; 3.00; 3.50; 4.00; 6.00; 8.00; 12.0; 24.0; 36.0; 48.0 and 72.0 h post-administration. Terbinafine levels were determined by high pressure liquid chromatography with tandem mass detection (HPLC-MS/MS) and the lower limit of quantification was set at 9.99 ng/mL. The pharmacokinetic parameters used for the bioequivalence assessment (AUClast, AUCInt and Cmax) were determined from the terbinafine concentration data using non-compartmental analysis. Classical 90 % confidence intervals (90CI) were calculated for the overall sample, and for males and females separately, and gender effects were investigated using an appropriate model. The results showed that overall classical 90CI were 96.08-105.40 % for AUClnt, 95.68-105.33 for AUClast and 88.24-112.83 for Cmax, that is, all within the predefined ranges for bioequivalence acceptance. Separate gender analysis showed very similar results for males and females when analysed independently, and no gender effects were detected (p>0.05 for all of the tested model effects).It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption. PB - Editio Cantor Verlag DO - 10.1055/s-0031-1297033 UR - http://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0031-1297033 ER -