Title: Study on pharmacokinetics and relative bioavailability of loxoprofen capsule in healthy volunteers
Abstract: Objective: To establish a LC/MS method for determination of the plasma concentration of loxoprofen in human plasma and to study its pharmacokinetics and relative bioavailability.Methods: Eighteen healthy volunteers were given 60 mg test or reference loxoprofen orally in a randomized crossover study.The concentration of loxoprofen in plasma was determined by LC/MS method.The pharmacokinetic parameters were calculated and relative bioavailability was studied.Results: The linear range of loxoprofen was 0.025 5-10.2 μg/mL.The recovery rates at low,middle and high concentrations(0.10,2.65,7.65 μg/mL) were 90.9%,97.6% and 100.7%,respectively(n=5).Both intra-day and inter-day RSD were less than 12%.The t1/2 of test and reference preparations were(1.54±0.15) and(1.58±0.17) h,cmax were(5.06±0.99) and(4.64±0.75) μg/mL,tmax were(0.38±0.15) and(0.50±0.17) h;AUC0→8 were(7.17±1.20) and(6.94±1.05) μg·h·mL-1,AUC0→∞were(7.32±1.19) and(7.04±1.05) μg·h·mL-1,respectively.Relative bioavailability of the test preparation was(103.84±15.64)%.Conclusion: This method can be used to study the pharmacokinetics of loxoprofen in human.The two preparations are bioequivalent.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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