Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters.

To investigate the bioequivalence of miglitol orally disintegrating tablets in healthy Chinese volunteers based on pharmacodynamic (PD) and pharmacokinetic (PK) parameters. Additionally, the safety profile was estimated. Two randomized, open-label, single-dose, crossover trials were conducted under fasting conditions. In the PD trial (CTR20191811), 45 healthy volunteers were randomly divided into 3 groups in a 1:1:1 ratio and administered sucrose alone or coadministered with 50 mg of miglitol orally disintegrating tablet test or reference formulation/sucrose. In the PK trial (CTR20191696), 24 healthy volunteers were randomized (1:1) to receive the test or reference formulation (50 mg). Blood samples were collected at 15 and 17 sampling points per cycle in the PD and PK trials, respectively. Plasma miglitol and serum glucose concentrations were analyzed using a validated liquid chromatography-tandem mass spectrometry method. Serum insulin concentrations were measured using electrochemiluminescent immunoassay. Statistical analyses for the PD and PK parameters were subsequently performed. The volunteers' physical indicators were monitored and documented during the entire study to estimate drug safety. The PD and PK parameters of the two formulations were similar. The main PD and PK end points were both within the prespecified range of 80%-125%. The incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were similar between the test and reference formulation groups, and no serious TEAEs or deaths occurred during the 2 trials. These 2 formulations were demonstrated to be bioequivalent and well tolerated in healthy Chinese volunteers under fasting condition.

[Effect of Parasep® feces centrifuge tube method on detecting schistosome eggs].

OBJECTIVE: To evaluate the effect of the Parasep® feces centrifuge tube method on detecting schistosome eggs. METHODS: A total of 803 residents aged from 6-65 years were selected in 2 schistosomiasis endemic villages, Jiangling County, Hubei Province, and their stool samples were collected and detected parallelly by the Kato-Katz technique, nylon silk egg hatching method, and Parasep® feces centrifuge tube method at the same time. RESULTS: Among the 803 people, 15 cases were found of schistosome egg positive, and the positive rate was 1.87%. The positive rates of the Kato-Katz technique, nylon silk egg hatching method, and Parasep® feces centrifuge tube method were 0.75%, 1.49% and 1.12%, respectively. The schistosome eggs got with the Parasep® feces centrifuge tube method were clear and easy to identify. CONCLUSION: In low endemic areas of schistosomiasis, the Parasep® feces centrifuge tube method can be used as schistosomiasis japonica etiology diagnosis method.

[Surveillance of endemic situation of schistosomiasis in a national surveillance site in Jiangling County from 2005 to 2011].

OBJECTIVE: To understand the dynamics of schistosomiasis japonica in a national surveillance site in Jiangling County, Hubei Province, China, so as to provide the evidence for formulating the intervention strategy of schistosomiasis control in the whole county. METHODS: The surveillance was performed in the surveillance village according to The National Surveillance Scheme of Schistosomiasis japonica, and the results were analyzed statistically from 2005 to 2011. RESULTS: The schistosome infection rates in residents and cattle decreased from 1.83% and 11.67% in 2005 to 0.91% and 0 in 2011, respectively. The density of living Oncomelania hupensis snails, the density of infected snails, and the infection rate of snails decreased from 4.02/0.1 m2, 0.014 5/0.1 m2, and 0.36% in 2005 to 0.70/0.1 m2, 0.000 3/0.1 m2, and 0.04% in 2011, respectively. CONCLUSIONS: The transmission of schistosomiasis in the surveillance site shows a gradually decreasing trend year by year, but the prevalence is still not stable. Therefore, the comprehensive interventions with the main effort for the infectious source control still need to be strengthened.