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Background: To assess the bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo® regarding pharmacokinetics (PK), pharmacodynamics (PD), and safety in Chinese healthy male participants. Methods: A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo® in 40 healthy participants. The primary PK endpoints were the area under the curve of glargine metabolites, M1 concentration from 0 to 24 hours (AUC0-24h), and the maximum glargine concentration within 24 hours post-dose (Cmax). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUCGIR.0-24h) and the maximum GIR within 24 hours post-dose (GIRmax). Results: GL Glargine U300 demonstrated comparable PK parameters (AUC0-24h, Cmax, AUC0-12h, and AUC12-24h of M1) and PD responses [AUCGIR.0--24h, GIRmax, AUCGIR.0-12h, and AUCGIR.12--24h] to those of Toujeo®, as indicated by 90% confidence intervals ranging from 80% to 125%. No significant disparities in safety profiles were observed between the two treatment groups, and there were no reported instances of serious adverse events. Conclusion: The PK, PD, and safety of GL glargine U300 were bioequivalent to that of Toujeo®. [ABSTRACT FROM AUTHOR]

The study aims to investigate the adhesion of a hydrogel made of cross-linked low-methyl esterified pectin to rat intestinal serosa ex vivo. The adhesivity of the FeP hydrogel, which was cross-linked by Fe3+ cations, exceeded that of hydrogels cross-linked by Ca2+, Zn2+, and Al3+ cations. The concentration of the cross-linking cation failed to influence the adhesion of the pectin hydrogel to the serosa. The mechanical properties and surface microrelief of the pectin hydrogel were influenced by the type and concentration of the cross-linking cations. Fe3+ cations form a harder and more elastic gel than Ca2+ cations. Scanning electron microscopy analysis revealed the characteristic surface pattern of FeP hydrogel and its denser internal structure compared to Ca2+ cross-linked hydrogel. The effect of the salt composition of the adhesion medium was shown since the FeP hydrogel's adhesion to the serosa was lower in physiological solutions than in water, and adhesion in Hanks' solution was higher than in phosphate buffered saline. Serum proteins and peritoneal leukocytes did not interfere with the serosal adhesion of the FeP hydrogel. Pre-incubation in Hanks' solution for 24 h significantly reduced the adhesion of the FeP hydrogel to the serosa, regardless of the pH of the incubation. Thus, serosal adhesion combined with excellent stability and mechanical properties in physiological environments appeared to be advantages of the FeP hydrogel, demonstrating it to be a promising bioadhesive for tissue engineering. [ABSTRACT FROM AUTHOR]

Insulin glargine is a long-acting insulin analog, which plays an important role in the treatment of diabetes mellitus. Biosimilar products of insulin glargine can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. This article presents a randomized, double-blind, single-dose, two-treatment, four-period, replicate crossover, euglycemic clamp study which was designed to evaluate the PK and PD similarity between the recombinant insulin glargine developed by Wanbang (test) and Lantus® (reference) in healthy volunteers. Subjects received subcutaneous administration of the insulin glargine formulation (0.4 U/kg) on two occasions for the test and reference drug, respectively, and a 20% dextrose solution was infused at variable rate to clamp the blood glucose concentrations at 0.3 mmol/L below the subjects' fasting glucose for 24 h. Taking advantage of the improved sensitivity of the bioanalytical method applied and the solution of the matrix stability problem, the parent insulin glargine was determined in the vast majority of plasma samples using a fully validated UHPLC-MS/MS method. The PK characteristics of the parent insulin glargine were revealed for the first time: after subcutaneous injection, concentrations of the parent insulin glargine increased to a relative high level within 3 h, and then, a relatively flat concentration-time profile lasting for at least 12 h post-dose was observed. For the first time, the pharmacokinetic parameters of the parent insulin glargine were used as endpoints for similarity evaluation, which complied with the regulatory guidance better and made the similarity conclusion more powerful. The ratios of geometric means of all PK and PD endpoints were close to 100.00%. For the PK endpoints (AUC0-24h, Cmax, AUC0-12h, and AUC12-24h of the parent insulin glargine and its metabolite M1), the 90% confidence intervals of geometric mean ratios of test to reference were entirely contained within 80.00%-125.00%. For the PD endpoints [AUCGIR(0-24h), GIRmax, AUCGIR(0-12h), and AUCGIR(12-24h)], the 95% confidence intervals of geometric mean ratios of test to reference were entirely contained within 80.00%-125.00%. Based on the above mentioned results, it can be concluded that the PK and PD characteristics of the biosimilar drug developed by Wanbang are similar to those of Lantus. [ABSTRACT FROM AUTHOR]

Banana fruit rot is a common postharvest disease of the banana fruit. The appearance of rot symptoms on the surface of the fruits reduces the quality and marketability of banana. From rot lesions on banana fruits, three Aspergillus isolates were isolated. Based on morphological characteristics and sequences of Internal Transcribed Spacer, β-tubulin and calmodulin, the isolates were identified as A. tamarii. Pathogenicity tests of the isolates, conducted using mycelial plugs with wounded and unwounded treatments, showed A. tamarii as the pathogen of banana fruit rot. Rot symptoms were highly severe on wounded banana fruits compared to unwounded fruits, and therefore, wounded banana fruits are more susceptible to A. tamarii infection. To the best of our knowledge, this is the first report of A. tamarii as a causal pathogen of banana fruit rot. This study indicated A. tamarii is one of postharvest rot pathogens of banana. [ABSTRACT FROM AUTHOR]

Introduction: Marginal and internal fit of a metal crown are very important for a successful metal crown prosthesis. This study will evaluate the marginal and internal fit of metal crowns produced from wax patterns that are formed by two different wax pattern fabrication procedures: conventional wax pattern fabrication and wax pattern milled using the computer-aided design and manufacture (CAD CAM) method. Objectives: To evaluate the marginal and internal fit of metal crowns over prepared tooth made from wax patterns made by conventional technique and CAD CAM technique. Methodology: A total of 21 participants with endodontically restored mandibular first molar will be selected. Two all-metal crowns will be made for each participant, thus 42 metal crowns in total will be made. These 42 metal crowns will be divided into two groups based on the method used to create wax patterns: metal crowns made using conventional hand-carved wax pattern technique (Group I, n=21) and metal crowns made using CAD CAM-milled wax pattern technique (Group II, n=21). Then, the marginal and internal fit of metal crowns from both groups will be compared. Expected results: It is expected that metal crowns made by CAD CAM milled wax pattern fabrication method will have better marginal and internal fit than those of conventional method. Conclusions: The clinical acceptability and success of the dental crown will be assessed by this study. Minimal marginal gap and better internal fit of all metal crown are key qualities.