title: Pharmacokinetics and bioequivalence study of two brands of loxoprofen tablets in healthy volunteers.
abstract: 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 pharmacokinetic parameters, including AUC(infnity), AUC(t), C(max), T(max), T1/2, and Ke were determined 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.
authors.affiliation: Department of Practical Arts Education, Gongju National University of Education, Gongju-Si, Chungnam, South Korea.
authors.forename: Ok Hwa
authors.initials: OH
authors.lastname: Jhee
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Lee
authors.forename: Leslie M
authors.initials: LM
authors.lastname: Shaw
authors.forename: Seo Eun
authors.initials: SE
authors.lastname: Lee
authors.forename: Jin Hee
authors.initials: JH
authors.lastname: Park
authors.forename: Ju Seop
authors.initials: JS
authors.lastname: Kang
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D010666:Phenylpropionates / Q000008:administration & dosage / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007202:Indicators and Reagents; D010666:Phenylpropionates; D013607:Tablets; C040656:loxoprofen