Title: Bioequivalence of sertraline hydrochloride dispersible tablet in Chinese healthy volunteers
Abstract: Objective To study the relative bioavailability and bioequi-valence of sertraline hydrochloride dispersible tablets in healthy volunteers. Methods A single oral dose (100 mg of tested and reference formulation) were given to 20 healthy volunteers in a randomised crossover study. The concentrations of srtraline in plasma were determined by HPLC. The pharmacokinetic parameters were calculated and the bioavai-lability and bioequivalence of two formulations were evaluated by DAS program.Results After a single dose, the pharmacokinetic parameters for srtraline were as follows: Cmax were (42.11±3.48),(42.76±4.19)μg·L-1; tmax were (3.45±0.51),(4.60±0.94) h ; AUC(0-120) were (1.61±0.17),(1.60±0.20) mg·h·L-1; AUC(0-∞) were (1.68±0.18),(1.68±0.20) mg·h·L-1 for tested and reference formulation respectively. Te relative bioavailability was (101.08±9.10)%.Conclusion The results of the statistic analysis showed that the two formulations were bioequivalence.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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