An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers

Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg chewable tablets and drug Riopan 800 mg chewable tablets in healthy volunteers.

开始日期2021-07-07

申办/合作机构

Valenta Pharmaceuticals JSC

100 项与 Magaldrate 相关的临床结果

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100 项与 Magaldrate 相关的转化医学

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100 项与 Magaldrate 相关的专利（医药）

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项与 Magaldrate 相关的文献（医药）

2024-11-01·Advances in Therapy

Evaluation of Aluminum and Magnesium Absorption Following the Oral Administration of an Antacid Suspension Containing Magaldrate in Healthy Women Under Fed Conditions

Article

作者: do Prado Assunção, Leandro ; Arbeláez Quintero, Isaac ; Calafatti Carandina, Silvana Aparecida ; Iorgatchof Xavier, Kamila ; Cruz Palacios, Maria Juliana ; Burgos Castillo, Maria Juliana

INTRODUCTIONAntacids are commonly used during pregnancy, and they are approved for the relief of symptoms of gastroesophageal reflux disease (GERD) during pregnancy. However, there are no reports of the quantification of the absorption of aluminum and magnesium in the antacid magaldrate in women. The aim of this study was to quantify the rate and magnitude of absorption of aluminum and magnesium in magaldrate.METHODSAn open-label, controlled, randomized, one-treatment study with a two-group design was conducted in healthy women in a fed state. The volunteers had a standard breakfast, and 30 min later, they were given a single-medication sachet containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate, and 120 mg of simethicone (group A, n = 8) or no medication (group B, n = 2). Blood samples were obtained 36 h before and up to 12 h after antacid administration. The method used for quantification was inductively coupled plasma-mass spectrometry.RESULTSThere was no absorption of aluminum in any of the blood samples from the healthy volunteers who received the drug or in those from the control group. Magnesium was detected at normal concentrations.CONCLUSIONThese findings suggest that the use of this antacid is safe and without risk in healthy women, including pregnant women.CLINICAL TRIAL REGISTRATIONClinicaltrials.gov registration: NCT06367452.

Otolaryngology–Head and Neck Surgery

Effectiveness of Changing Drug Classes in Patients With Refractory Laryngopharyngeal Reflux Disease

Article

作者: Saussez, Sven ; Lechien, Jérôme R. ; Herman, Emilie

AbstractObjectiveTo investigate the effectiveness of drug class changes in patients with refractory laryngopharyngeal reflux disease (LPRD).Study DesignRetrospective case series with prospective data.SettingMulticenter study.MethodsThe data of patients treated for a refractory LPRD from September 2017 to December 2023 were collected. The effectiveness of drug class changes was assessed through the reflux symptom score (RSS) change. Signs were evaluated with the Reflux Sign Assessment. The RSS reduction was used to categorize the therapeutic responses as mild (20%‐40% RSS reduction), moderate (40.1%‐60% RSS reduction), high (60.1%‐80%), and complete (>80%).ResultsAmong the 334 medical records, 74 (22.2%) patients had refractory LPRD defined as no RSS change in the pre‐ to 3‐month posttreatment. The mean age was 52.6 ± 15.5 years. Changing drug class was associated with significant 3‐ to 6‐month posttreatment reductions of RSS and RSA. Thirty patients (39%) did not experience symptom reduction after changing drugs. Changing alginate to magaldrate and magaldrate to alginate was associated with the highest responder rate (76.9%). Changing PPI and alginate/magaldrate molecules led to a response rate of 62.5%. In patients initially treated with a combination of PPI and alginate or magaldrate, changing PPI without changing alginate/magaldrate led to a 37.5% response rate. The baseline RSS was predictive of the 3‐ and 6‐month RSS (therapeutic response).ConclusionChanging drug class, especially alginate‐to‐magaldrate, may be an effective therapeutic approach for patients with a refractory LPRD.

100 项与 Magaldrate 相关的药物交易

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