12 4 The laboratory test result and outlines for indivdual subjects
Only 2 subjects showed abnormal blood routine,No .113 subject showed increased eosinophil percentage and increased basophil percentage,No. 216 subject showed the amount of neutrophils decreasing and that of leukocytes decreasing Biochemical abnormalities include blood uric acid araising. FBG decreasing and triglycerides araising .Blood routine, blood blochemical, urine routine, coagulationtest results and abnormal values of the subjects are shown in appendix 12 statisticalanalysis report table 18.104.22.168.1-3 and 22.214.171.124
12.5 Vital signs, physical examination, and ecg
The test didn't show abnormal vital signs and physical examination.Only 1 subject showed abnormal 12 lead ECG,judging as connective arthythmia,happening affer 2 days of giving the medicine,with a duration of 51 minutes and recovery afterno intervention, the researchers determined that there was a reasonable possibilitywith the drug.
12.6 Security conclusion
Of the subjects using mp-513 (20mg) 7 subjects(43.8 percent) had at least one adverse event and 6 subjects (37.5 percent) had at least one adverse drug reaction.There were no deaths, serious adverse events, or serious adverse drug reactions among the subjects in this group of the subjects using mp-513 (40mg). 5 subjects(31.3 percent) had at least one adverse event and drug reaction,and 1 subject(6.3 percent) had serious adverse events and drug reaction.There were no deaths. Of the subjects using mp-513 (80mg) 5 subjects(31 3 percent) had at least one adverse event and drug reaction There were no deaths or serious adverse drug reactions among the subjects in this group .The vital signs measurements and laboratory tests in the 20mg dose group were not out of the normal range and had cinical significance. All subjects AE returned to nomal .No subjects withdrew from the trial because of adverse events. The incidence of AE was not relaled to dose and systemic exposure.