RESUMO
AIM: To compare the pharmacokinetic behavior of a single oral sorafenib tosylate tablets in Chinese healthy subjects under fasting conditions and evaluate the bioequivalence of the test reagent (T) and the reference reagent (R). METHODS: A single-center, randomized, open-labeled, two-agent, three-period, three-sequence (TRR, RTR, RRT), and partially repeated crossover trial design was adopted. The trial was administered once per cycle (0.2 g) under fasting conditions. 36 healthy subjects were randomly divided into 3 groups, each with 12 cases. RESULTS: Thirty-six healthy subjects (9 females, average age 31 years) were enrolled in the trial. The upper limits of the one-sided 95% confidence interval of the pharmacokinetic parameters C
RESUMO
AIM: To sort out the research context of information construction of drug clinical trials and understand the hot spots and development trend of informatization construction of drug clinical trials. METHODS: The knowledge map CiteSpace software was applied to analyze the 391 items of literature collected from China CNKI database during the year of 2000 to 2020. A thorough investigation was conducted from the perspectives of quantitative analysis, research institutes, author, research hot topics and the research trend. A knowledge map was generated to sort out the main ideas of the research of the drug clinical trial information construction. RESULTS: The results showed that in the past 20 years, the number of published papers related to the construction of clinical information of drugs fluctuated, and most of the major research institutions had strong research ability in this field. But the interactions within research institutions remained improved, and the academic exchanges between scholars still needed to be strengthened. The shift in hot-spot research reflected a greater focus on systematizing and protecting subjects' rights. CONCLUSION: The research of information construction of drug clinical trial mainly focuses on clinical trial, drug clinical trial, quality control and other aspects. It is the trend of future research to further improve the efficacy of trial management through information construction, ensure the reliability and standard of drug clinical trials, and effectively reduce the risks and hidden dangers of drug clinical trials.