Bioequivalence of Meloxicam capsule in healthy volunteers

OBJECTIVE To study the bioequivalence of Meloxicam capsules(test preparation) and Meloxicam tablets(reference preparation) in Chinese healthy volunteers.METHODS An HPLC-UV assay method for determining the concentration of meloxicam in human plasma was developed and validated.This method was applied to a clinical pharmacokinetic study of meloxicam in 20 healthy subjects using a two-stage,cross over study design.The subjects sequentially received single oral doses of 15 mg of meloxicam(reference or test preparations).During each stage,multiple blood samples were collected and the drug plasma concentrations were measured.The pharmacokinetic parameters i.e.AUC,t1/2 were calculated and utilized to evaluate the bioequivalence between the two preparations.RESULTS The t1/2 for reference and test products were 26.56±7.57 and 24.61±10.46 h,respectively,while the Cmax were 2.49±0.37,2.45±0.33 μg·mL-1 for reference and test preparation,respectively.The Tmax for reference and test products were 5.05±1.51,4.58±1.35 h,respectively,while the AUC0→t were 84.12±19.91,76.57±17.71 μg·h·mL-1 for reference and test preparations,respectively.The relative bioavailability of Meloxicam Capsules is 92.8%±17.7%.CONCLUSION The test preparation is bioequivalent with the reference preparation in healthy volunteers.