Pharmacokinetics and bioequivalence study of two brands of loxoprofen tablets in healthy volunteers

The aims of this study were to assess the pharmacokinetics and bioequivalence of two brands of loxoprofen (CAS 80832-23-6) 60 mg tablets in healthy male volunteers. The several pharmacokinetic parameters were evaluated after an oral administration after an overnight fast according to a single dose, two-sequence, and cross-over randomized design with a 1-week washout interval. Serial blood samples were collected throughout 10 h after administration of the reference and test drug. Plasma was analyzed by validated HPLC with UV detection. Several pharmacoki-netic parameters, including AUC infinity , AUC t , C max , T max , T 1/2 , and Ke were deter-mined from blood concentrations of both formulations. AUC t , AUC infinity and C max were evaluated for bioequivalence after log-transformation of data using ANOVA with 90 % confidence interval level. The parametric 90 % confidence intervals of AUC t , AUC infinity , and C max were 90.13– 106.34 %, 91.43–106.94 %, and 91.17– 108.53 %, respectively. All of the tested parameters were within the acceptable range of 80–125 %. Based on these statistical considerations, it was concluded that the test drug was bioequivalent to the reference drug.