Pharmacokinetics and bioavialability of nimesulide dispersible tablet
Ying Fu
Abstract
Ying Fu
Abstract
Aim To study the pharmacokinetics and bioequivalence of nimesulide dispersible tablet and its normal tablet. Methods 20 healthy volunteers were treated with a single oral dose of domestic nimesulide dispersible tablet or normal tablet (control) in a randomized crossover study and the plasma drug concentration was determined by HPLC. Results The plasma concentration time curve was fitted to the one compartment model. The pharmacokinetic parameters obtained were: c max ( 3.91 ± 0.74) μg ·ml -1 , t (1/2)β ( 3.40 ± 0.78) h , t max ( 3.15 ± 0.67) h , AUC 0~24 ( 31.92 ± 6.36) μg ·ml·h -1 , there was no significant difference between the active and control groups. The relative bioavailability obtained was ( 96.43 ± 8.41 ) %. Conclusion The pharmacokinetic profile for the 2 tablets was similar so it may be concluded that they are bioequivalent.
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Aim To study the pharmacokinetics and bioequivalence of nimesulide dispersible tablet and its normal tablet. Methods 20 healthy volunteers were treated with a single oral dose of domestic nimesulide dispersible tablet or normal tablet (control) in a randomized crossover study and the plasma drug concentration was determined by HPLC. Results The plasma concentration time curve was fitted to the one compartment model. The pharmacokinetic parameters obtained were: c max ( 3.91 ± 0.74) μg ·ml -1 , t (1/2)β ( 3.40 ± 0.78) h , t max ( 3.15 ± 0.67) h , AUC 0~24 ( 31.92 ± 6.36) μg ·ml·h -1 , there was no significant difference between the active and control groups. The relative bioavailability obtained was ( 96.43 ± 8.41 ) %. Conclusion The pharmacokinetic profile for the 2 tablets was similar so it may be concluded that they are bioequivalent.
Key concepts: Bioequivalence, Nimesulide, Pharmacokinetics, Bioavailability, Crossover study, Pharmacology, Plasma concentration, High-performance liquid chromatography