Relative bioavail ability of domestic nimesulide tablet
Xiao Yan Tang
Abstract
Xiao Yan Tang
Abstract
The pharmacokinetics of domestic or imported nimesulide tablet was determined following a single oral dose of 200 mg given to 10 volunteers in randomized crossover study. The plasma concentration of nimesulide was assayed by HPLC method. The concentration -time curve of nimesulide conformed to a one-compartment model and the main parameters of domestic nimesulide were as follows: T1/2Ke 3. 61±1.43 h; Tpeak 2. 07±0. 63 h; Cmax=9. 46±2. 06 mg·L-1 ; AUC = 76. 39±17. 62 mg·L-1·h-1 respectively. The relative bioavailability of domestic tablet was 92.2%. The results of three factors analysis of variance and Bayesian method showed that two formulation were bioequiva-lent.
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The pharmacokinetics of domestic or imported nimesulide tablet was determined following a single oral dose of 200 mg given to 10 volunteers in randomized crossover study. The plasma concentration of nimesulide was assayed by HPLC method. The concentration -time curve of nimesulide conformed to a one-compartment model and the main parameters of domestic nimesulide were as follows: T1/2Ke 3. 61±1.43 h; Tpeak 2. 07±0. 63 h; Cmax=9. 46±2. 06 mg·L-1 ; AUC = 76. 39±17. 62 mg·L-1·h-1 respectively. The relative bioavailability of domestic tablet was 92.2%. The results of three factors analysis of variance and Bayesian method showed that two formulation were bioequiva-lent.
Key concepts: Nimesulide, Bioavailability, Pharmacokinetics, Cmax, Chemistry, Crossover study, Bioequivalence, Pharmacology