The evaluation of the quantitative relationship between the healthy volunteers' plasma concentration after continuous administration with moxifloxacin and QTc prolongation / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the effect on QT interval of the healthy volunteers who was after four consecutive days of oral moxifloxacin. METHODS: The 48 volunteers (24 male and 24 female) of 20-40 years old were selected in accordance with the parameters of physical examination and laboratory test. For four consecutive days, the volunteers take oral moxifloxacin 400 mg qd. Before administration and after, ECGs were traced for each preset time point. Analysis the QT by manual measurement and measuring instruments. While, the blood samples for each preset time point were collected for the analysis of blood concentration by LC-MS/MS. At the end of a cycle do the safety checks for the healthy volunteers according to program requirements. RESULTS: The 48 healthy volunteers were selected in the trial, and 45 (22 males and 23 female) of them completed. After four consecutive days to give oral moxifloxacin qd can cause QT prolongation, the degree of risk of that is possibly dangerous. CONCLUSION: Moxifloxacin can cause QT prolongation, and the quantitative relationship between plasma concentration and QT prolongation is positive correlation, it is suggested that clinicians should pay strict attention to the administration of serious drug reactions.