[Translation] A single-center, randomized, open-label, single-dose, two-drug, self-crossover bioequivalence study of Al-Mg-Pirine Tablets (II) in healthy volunteers

本次试验以广州大光制药有限公司研发的铝镁匹林片（Ⅱ）为受试制剂，按生物等效性研究的有关规定，以铝镁匹林片（Ⅱ）（Lion Corporation生产，商品名：BUFFERIN）为参比制剂，考察两种制剂的相关药代动力学参数和相对生物利用度，评价两者在单次给药后（空腹和餐后）是否具有生物等效性。

[Translation]

In this trial, Aluminum Magnesium Aspirin Tablets (II) developed by Guangzhou Daguang Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant regulations of bioequivalence studies, Aluminum Magnesium Aspirin Tablets (II) (produced by Lion Corporation, trade name: BUFFERIN) was used as the reference preparation. The relevant pharmacokinetic parameters and relative bioavailability of the two preparations were investigated, and whether the two preparations were bioequivalent after a single dose (fasting and postprandial) was evaluated.

Start Date-

Sponsor / Collaborator

Guangzhou Daguang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dihydroxyaluminum aminoacetate

100 Translational Medicine associated with Dihydroxyaluminum aminoacetate

100 Patents (Medical) associated with Dihydroxyaluminum aminoacetate

Literatures (Medical) associated with Dihydroxyaluminum aminoacetate

01 Oct 2024·Clinical Pharmacology in Drug Development

Pharmacokinetic and Bioequivalence Evaluation of Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate, and Aspirin Tablets in Healthy Chinese Subjects in the Fasting and Postprandial Conditions

Article

Author: He, Yingxia ; Yao, Fang ; Liu, Yang ; Cao, Dan ; Xie, Yafang ; Liu, Qiangwei ; Liu, Guan ; Liang, Jun ; Li, Xiuwen ; Lu, Pan ; Wang, Jie

AbstractDihydroxyaluminum aminoacetate, heavy magnesium carbonate, and aspirin tablets is a new combined aspirin preparation, each containing aspirin (81 mg), dihydroxyaluminum aminoacetate (11 mg), and heavy magnesium carbonate (22 mg). This study was conducted to evaluate the pharmacokinetic (PK) and bioequivalence in healthy Chinese subjects. This randomized, open‐label, single‐dose, 2‐sequence, and 2‐period crossover study included 78 healthy volunteers (fasting, n = 36; postprandial, n = 42). Blood samples were collected for PK analysis. Aspirin and salicylic acid concentrations in human plasma were determined by liquid chromatography‐tandem mass spectrometry. Safety and tolerability were monitored. There were no significant differences between the test and reference formulations in maximum plasma concentration, area under the plasma concentration‐time curve (AUC) from time 0 to time t, or AUC from time 0 to infinity. The 90% confidence intervals of the test and reference formulations of maximum plasma concentration, AUC from time 0 to time t, and AUC from time 0 to infinity were within the acceptable range (80%‐125%) under fasting and postprandial conditions. All adverse events were mild and no serious adverse events were observed in the study. Both compounds were well tolerated in healthy Chinese volunteers.

01 Oct 2014·AAPS PharmSciTechQ3 · MEDICINE

Rheological Characterization of Cataplasm Bases Composed of Cross-Linked Partially Neutralized Polyacrylate Hydrogel

Q3 · MEDICINE

Article

Author: Jian Wang ; Teng Shen ; Hongqin Zhang ; Jian Yu ; Jianxin Wang ; Dianyun An ; Wei Li

Viscoelasticity is a useful parameter for characterizing the intrinsic properties of the cross-linked polyacrylate hydrogel used in cataplasm bases. The aim of this study was to investigate the effects of various formulation parameters on the rheological characteristics of polyacrylate hydrogel. The hydrogel layers were formed using a partially neutralized polyacrylate (Viscomate(™)), which contained acrylic acid and sodium acrylate in different copolymerization ratios, as the cross-linked gel framework. Dihydroxyaluminum aminoacetate (DAAA), which produces aluminum ions, was used as the cross-linking agent. Rheological analyses were performed using a "stress amplitude sweep" and a "frequency sweep". The results showed that greater amounts of acrylic acid in the structure of Viscomate as well as higher concentrations of DAAA and Viscomate led to an increase in the elastic modulus (G'). However, greater amounts of acrylic acid in the structure of Viscomate and higher concentrations of DAAA had an opposite on the viscous modulus (G″); this might be owing to higher steric hindrance. The results of this study can serve as guidelines for the optimization of formulations for cataplasms.

01 Dec 2009·Clinical and Experimental MedicineQ3 · MEDICINE

A retrospective analysis of changes in inflammatory markers in patients treated with bacterial viruses

Q3 · MEDICINE

Article

Author: Ryszard Międzybrodzki ; Wojciech Fortuna ; Andrzej Górski ; Beata Weber-Dąbrowska

Bacteriophages are increasingly considered an alternative to antibiotics for the treatment of bacterial infections. Clinical improvement may be associated with a lowering of inflammatory markers during the antibiotic treatment of bacterial infections. Some experimental data suggest that phage treatment may have anti-inflammatory properties. We present a retrospective analysis of C-reactive protein (CRP) serum concentration, erythrocyte sedimentation rate (ESR), and white blood cell count (WBC) measured in patients with chronic, symptomatic, antibiotic therapy-resistant bacterial infections who qualified for phage treatment within the protocol "Experimental Phage Therapy of Antibiotic Therapy-Resistant Infections, Including MRSA Infections". Data collected from 37 patients with osteomyelitis (with or without metal implants or joint endoprosthesis) or skin and soft tissue or lower respiratory tract infection induced by, in the majority of cases, S. aureus were analyzed. Phage preparations (natural phage lysates) were administered orally (one 10-ml ampoule three times daily after neutralization of gastric juice with 10 ml of dihydroxyaluminium sodium carbonate) and/or locally (one ampoule two times daily for wet compresses or irrigation of a fistula). No significant changes in mean serum levels of CRP measured after 5-8 days of phage administration were observed compared with the baseline CRP levels measured before therapy (35.7 vs. baseline 38.6 mg/l, n = 11). However, a significant decrease in mean CRP values measured later, between days 9 and 32, was noted (16.1 vs. baseline 23.3 mg/l, n = 26, P < 0.05). Similar tendencies were observed in the changes in mean WBC values, but mean ESR in the patients before, in the early phase, and later during therapy did not change significantly. This is the first report suggesting that the application of phage preparations may probably influence and diminish the inflammatory reaction that accompanies bacterial infection.

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