2001Zhongguo linchuang yaolixue yu zhiliaoxueRequires access

Pharmacokinetics and bioavialability of nimesulide dispersible tablet

Ying Fu

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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.

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Available 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.

Key concepts: Bioequivalence, Nimesulide, Pharmacokinetics, Bioavailability, Crossover study, Pharmacology, Plasma concentration, High-performance liquid chromatography

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