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目的:探讨地芬尼多试验药和参比药在健康人体中是否生物等效。方法:采用双周期试验设计,12名健康志愿者分别单次口服地芬尼多试验药和参比药50 mg,采用GC-MS方法测定地芬尼多血浓度。用DAS软件计算药物动力学参数,用SPSS软件进行t检验和双因素方差分析。结果:试验药和对照药生物不等效。主要药物动力学参数Ke、t_(1/2)和C_(max)在性别因素上存在统计学差异,在剂型因素上无统计学差异;Ka、V/F、AUC_(0-36)和AUC_(0-∞)在剂型因素和性别因素上均不存在统计学差异。结论:单次口服试验药50 mg后,不同性别受试者部分药物动力学参数存在差异。
OBJECTIVE: To investigate whether bioequivalence of defensino and reference drugs in healthy volunteers. Methods: Twelve-week experimental design was adopted. Twelve healthy volunteers were given a single oral dose of 50 mg of the Finnish test drug and reference drug, respectively, and the plasma concentration of denphenidyl was determined by GC-MS. Pharmacokinetic parameters were calculated using DAS software, t test and two-way ANOVA with SPSS software. Results: The test drug and control drug are not equivalent. The main pharmacokinetic parameters Ke, t_ (1/2) and C_ (max) were statistically different in gender, and there was no significant difference in dosage form factors; Ka, V / F, AUC_ (0-36) and AUC_ (0-∞) There was no statistical difference in dosage form factors and gender factors. Conclusion: Some pharmacokinetic parameters of different gender subjects are different after a single oral test of 50 mg.