Pharmacokinetic and Bioequivalence Evaluation of Two Cefprozil Dispersible Tablets in Healthy Chinese Volunteers.

This study aimed to assess the bioequivalence of 2 cefprozil dispersible tablet formulations (250 mg) in healthy Chinese volunteers under fasting and fed conditions and to determine the pharmacokinetics of cefprozil. A randomized, single-dose, open-label, 2-formulation, 2-period study was conducted. The elimination period for this study was 7 days. Forty-eight healthy volunteers received 250-mg cefprozil dispersible tablets in each study period under both test and reference conditions. The test and the reference cefprozil were bioequivalent in healthy Chinese volunteers, and there was no significant food effect in individuals receiving either formulation. No serious adverse event was recorded, and no volunteers withdrew from the study.

Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10-mg Rivaroxaban Tablets: A 4-Period Crossover Trial.

This study compared the safety, bioequivalence, and pharmacokinetic properties of 2 formulations of 10-mg rivaroxaban tablets in healthy Chinese participants in fasting and fed arms. The trial was an open, randomized, 4-period, replicated crossover scheme, and 36 volunteers were recruited separately for the fasting and fed arms. Volunteers were randomly administered a single dose of the test or reference formulation (10 mg) orally, followed by a 5-day washout period. Rivaroxaban concentrations in the plasma were determined using liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were obtained from the concentration-time profiles. The mean values of the test and the reference product for the area under the plasma concentration-time curve from time 0 to the last measurable concentration, area under the plasma concentration-time curve from time 0 to infinity, and maximum plasma concentration were 996 and 1014 ng • h/mL, 1024 and 1055 ng • h/mL, and 150 and 152 ng/mL in the fasting arm, respectively; the values were 1155 and 1167 ng • h/mL, 1160 and 1172 ng • h/mL, and 202 and 193 ng/mL in the fed arm, respectively. All the parameters were within acceptable limits in terms of bioequivalence. No serious adverse events were observed. This study demonstrated that the 2 rivaroxaban tablets were bioequivalent in healthy Chinese participants under fasting and fed conditions.

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Formulations of 0.2-g Ibuprofen Granules.

Ibuprofen is a nonsteroidal anti-inflammatory agent. In this study, we compared the pharmacokinetic properties, bioequivalence, and safety of a newly developed generic formulation (test) and a branded formulation (reference) of 0.2 g ibuprofen granules in healthy Chinese participants in fasting and fed arms. The randomized, single-dose, open-label, two-preparation, two-sequence, two-period crossover study had a washout period of 7 days between each period. It was conducted in 72 participants, 24 in the fasting arm and 48 in the fed arm. The concentration of ibuprofen in the plasma was determined using high-performance liquid chromatography-tandem mass spectroscopy. The primary pharmacokinetic parameters were calculated using a noncompartmental model. Safety assessments were performed throughout the study. The mean values of Cmax , AUC0-t , and AUC0-∞ for the test and reference preparations of ibuprofen were 19 295 and 21 101 ng/mL, 70 795 and 70 558 ng * h/mL, and 72 023 and 71 647 ng * h/mL, respectively, in the fasting arm and 11 299 and 11 605 ng/mL, 70 983 and 69 157 ng * h/mL, and 73 279 and 71 267 ng * h/mL, respectively, in the fed arm. For all parameters, bioequivalence was within acceptable limits. No serious adverse reactions were reported in this study. This study demonstrated that the 2 formulations of ibuprofen granules were bioequivalent in healthy Chinese volunteers under fasting and fed conditions.

Plasma proteins as potential targets of abnormal Savda syndrome in asthma patients treated with unique Uighur prescription.

The therapeutic effect of Uighur prescription on abnormal Savda in asthma patients was evaluated using plasma proteomics in order to elucidate the biological mechanism and identify potential therapeutic targets of abnormal Savda. In the present study, 40 asthma patients with abnormal Savda including abnormal Savda Munziq and Savda Mushil were enrolled and treated with Uighur prescription. The effect of Uighur prescription on protein expression and potential targets was investigated by isobaric tags for relative and absolute quantitation (iTRAQ)-based proteomics and bioinformatics analysis. Expression of candidate proteins was verified by an enzyme-linked immunosorbent assay. Following treatment with the Uighur prescription, 22 proteins were differentially expressed in the plasma of patients with asthma and abnormal Savda. The majority of these proteins were localized in intermediate filaments and the cytoskeleton and acted as antioxidant enzymes and binding proteins. Furthermore, they participated in the defense and inflammatory response, and the response to oxidative stress and wound healing. Peroxiredoxin 2 and carboxypeptidase B2 expression was significantly upregulated, whereas S100A7 was considerably downregulated in the whole plasma of patients (all P<0.05) in accordance with the iTRAQ proteomics data. Uighur prescription of abnormal Savda may affect the whole regulatory network of protein expression that is altered following the development of abnormal Savda in patients with asthma.

[Epidemiology survey of dental caries and fluorosis of children in Kunming city].

OBJECTIVE: To determine the feasibility of water fluoridation to prevent caries in Kunming by investigating the epidemiological status of dental caries and dental fluorosis of children, and to provide the longitudinal reference data for the long-term epidemiology survey of dental caries and dental fluorosis in Kunming city. METHODS: Through stratified cluster sampling method, 212 5-year-old children and 1149 12-year-old children were recruited in the survey. Dental caries condition of each child was clinically examined, dental fluorosis was examined in 12-year-old group. RESULTS: The prevalence of dental caries of primary teeth in 5-year-old group was 73.6%, mean value was 4.47 +/- 4.39. The values of permanent teeth in 12-year-old group were 53.5% and 1.42 +/- 1.83. The prevalence of dental fluorosis in 12-year-old group was 4.1% and the average community fluorosis index was 0.03. CONCLUSION: Based on the high prevalence of dental caries and the low prevalence of dental fluorosis, it is suggested that using water fluoridation to prevent caries is feasible and necessary in Kunming city.

[Antibacterial activity determination of six kinds of natural herbs in yunnan on normal oral predominant].

OBJECTIVE: To determine the antibacterial activity of six kinds of natural herbs in Yunnan on normal oral predominant bacteria in vitro. METHODS: Agar dilution method, the antimicrobial susceptibility testing of anaerobes which was recommended by National Committee for Clinical Laboratory Standard (NCCLs), was used to determine the antimicrobial susceptibility of herbs to 21 kinds of oral model strains and clinical isolates. The results were expressed by minimum inhibitory concentration (MIC). RESULTS: All six kinds of herbs were effective to the oral predominant bacteria. For the ten kinds of cariogenic bacteria, the MIC of caesalpinia sappan lignum was between 5-10 mg x mL(-1), and the MIC of other herbs was above 20 mg x mL(-1). For the eleven kinds of predominant bacteria which normally involved in pulp periapical disease and periodontitis, the MIC of caesalpinia sappan lignum was below 0.062 5 mg x mL(-1), and the MIC of the terminalia chebula retz was between 10-20 mg x mL(-1), and the others were above 20 mg x mL(-1). CONCLUSION: The six kinds of herbs in Yunnan could be used in treatment or prevention of oral bacterial diseases.