ABSTRACT
ObjectiveTo investigate the pharmacokinetic characteristics of sofosbuvir tablets, and to evaluate the bioequivalence and safety of two preparations. MethodsHealthy volunteers were recruited through the platform of clinical trial recruitment in The Affiliated Hospital of Changchun University of Chinese Medicine. Screening physical examination was performed for fasting group on September 18, 2018 and for postprandial group on September 28, 2018, and the volunteers were enrolled after their physical examination results met the inclusion criteria. The fasting group and the postprandial group, with 40 volunteers in each group, were given oral administration of the test preparation sofosbuvir tablets or the reference preparation sofosbuvir tablets (SOVALDI, 400 mg). This was a randomized, open-label, two-sequence, four-cycle, single-dose, and completely repeated cross-over bioequivalence test in the fasting or postprandial state in the healthy population; in the fasting group, 20 volunteers each received oral administration of the test preparation and the reference preparation, and in the postprandial group, 20 volunteers each received oral administration of the test preparation and the reference preparation. Liquid chromatography-tandem mass spectrometry was used to measure the content of sofosbuvir and its major metabolite GS-331007 in human EDTA-K2 plasma; the plasma concentration of sofosbuvir was measured at 15 time points from 0 hour to 8 hours after administration, and that of GS-331007 was measured at 16 time points from 0 hour to 72 hours after administration. WinNonlin software was used to calculate pharmacokinetic parameters and evaluate bioequivalence. ResultsAfter the administration of the test preparation and the reference preparation in the fasting state, when the pharmacokinetic parameters of sofosbuvir was used to evaluate the bioequivalence of the test preparation and the reference preparation, the ratios of the geometric means of Cmax, AUC0-t, and AUC0-inf were 90.55%, 97.26%, and 94.62%, respectively; when the pharmacokinetic parameters of GS-331007 was used to evaluate the bioequivalence of the test preparation and the reference preparation, the ratios of the geometric means of Cmax, AUC0-t, and AUC0-inf were 98.91%, 98.98%, and 99.46%, respectively. All of the above values were within the range of 80.00%-125.00%. An analysis of variance was performed after the pharmacokinetic parameters of sofosbuvir Cmax, AUC0-t, and AUC0-inf were transformed by natural logarithm, and the results showed that sequence, cycle, and preparation had no marked influence on Cmax, AUC0-t, and AUC0-inf (all P＞0.05). ConclusionThe test preparation of sofosbuvir tablets is bioequivalent to the reference preparation in the fasting and postprandial states.
ABSTRACT
Objective To investigate the polypropylene mesh used transvaginal Mesh for improve clinical efficacy and benefit the quality of life of pelvic organ prolapse( POP) .Methods 80 patients with POP were randomly divided into A group and B group,40 cases in each group.A group received vaginal mesh suspension surgery for treatment,B group used traditional vaginal hysterectomy and vaginal wall repair for treatment.The operation situations of the two groups preoperation and postoperation, the quality of life after 6 months were compared.Results In A group,the operative time[(83.32 ±21.34)min],blood loss[(87.43 ±33.52)mL],retention catheter time[(3.23 ± 0.54)d],postoperative hospital stay[(5.32 ±0.69)d]were significantly less than those in group B[(1 084.34 ± 27.88)min,(98.65 ±12.43)mL,(2.9 ±0.87)d,7.97d](all P<0.01),and the physiological function,physical function,bodily pain,general health,vitality,social functioning and mental health and other seven dimensions of A group were significantly improved,compared with group B(P <0.01).Conclusion Trans -vaginal Mesh has obvious therapeutic effect and improves patients'living quality on POP.It is worthy of clinical application.