Delving into the Latest Updates on Aluminum hydroxide/Magnesium Hydroxide with Synapse

The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.

Start Date09 Nov 2023

Sponsor / Collaborator

Stony Brook University

NCT01930045 / CompletedPhase 1

A Study to Evaluate the Effect of Staggered Dosing of a Magnesium/Aluminum Antacid on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Raltegravir-Containing Regimen

This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX) given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1 pharmacokinetics results before continuing to Part 2. The same participants participated in Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma concentration 12 hours after administration (C 12 hrs) would not differ significantly from raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after raltegravir.

Start Date01 Oct 2013

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT01281501 / CompletedPhase 4IIT

A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain

The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).

Start Date01 Jan 2011

Sponsor / Collaborator

University of Chulalongkorn

100 Clinical Results associated with Aluminum hydroxide/Magnesium Hydroxide

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100 Translational Medicine associated with Aluminum hydroxide/Magnesium Hydroxide

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100 Patents (Medical) associated with Aluminum hydroxide/Magnesium Hydroxide

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203

Literatures (Medical) associated with Aluminum hydroxide/Magnesium Hydroxide

01 Jul 2022·European Journal of Drug Metabolism and Pharmacokinetics

Results From Phase I Studies Investigating the Dose Linearity of Finerenone Tablets and the Influence of Food or pH-Modifying Comedications on its Pharmacokinetics in Healthy Male Volunteers

Article

Author: Nagelschmitz, Johannes ; Loewen, Stephanie ; Heinig, Roland

BACKGROUND AND OBJECTIVESFinerenone is a nonsteroidal mineralocorticoid receptor antagonist that reduces the risk of adverse kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes mellitus. Clinical phase I studies with finerenone were carried out to assess its pharmacokinetics and the influence of common covariables on its absorption after oral administration.METHODSThree crossover studies in healthy male volunteers with single-dose administration of finerenone investigated the dose linearity of a film-coated tablet (1.25-10 mg [n = 24] and 10-20 mg [n = 18]), the effect of food on the 20 mg tablet (n = 18), and the effects of the proton-pump inhibitor omeprazole (4 days pre-treatment and co-administration 2 h before finerenone) and an aluminum/magnesium hydroxide-containing antacid (10 mL [Maalox^®] 70 mVal, simultaneous intake) on the 10 mg tablet (n = 10 and n = 11, respectively).RESULTSFinerenone was rapidly absorbed (time to reach maximum plasma concentration [t_max] was 0.50-0.75 h). Area under the curve from zero to infinity (AUC_∞) and the maximum concentration (C_max) increased in proportion to dose in the range investigated in clinical phase II and phase III studies (1.25-20 mg), with point estimates for the ratio of dose-normalized AUC_∞ and C_max (20 mg/10 mg, approved therapeutic doses) of 0.9943 and 0.9301. After the administration of finerenone 20 mg with a high-fat, high-calorie meal, AUC_∞ increased (+ 21%), C_max decreased (-19%), and t_max was prolonged (2.47 vs. 0.75 h) when compared with the fasting state. Omeprazole had no effect on finerenone AUC_∞ and C_max. Maalox had no effect on finerenone AUC_∞ and led to a non-clinically-relevant decrease in C_max (-19%).CONCLUSIONSThe pharmacokinetics of the finerenone film-coated tablet were linear. High-fat, high-calorie food had no clinically relevant effect on the pharmacokinetics of finerenone. In addition, pH-modifying comedications were not found to alter the pharmacokinetics of finerenone and were deemed safe for co-administration.

01 May 2019·Clinical Pharmacology in Drug Development

Pharmacokinetic Interaction Study Between Saxagliptin and Omeprazole, Famotidine, or Magnesium and Aluminum Hydroxides Plus Simethicone in Healthy Subjects: An Open‐Label Randomized Crossover Study

Article

Author: Ren, Song ; Boulton, David W.

AbstractSaxagliptin is an orally administered, highly potent, and selective dipeptidyl peptidase‐4 inhibitor for the management of type 2 diabetes mellitus. This study was conducted to determine the effect of magnesium and aluminum hydroxides plus simethicone, famotidine, and omeprazole on the pharmacokinetics of saxagliptin and its active metabolite, 5‐hydroxy saxagliptin. This was an open‐label, randomized, 5‐treatment, 5‐period, 3‐way crossover study in 15 healthy subjects. Mean Cmax of saxagliptin was 26% lower, but AUC was almost unchanged when saxagliptin was coadministered with Maalox Max. Mean Cmax was 14% higher, but AUC was almost unchanged when saxagliptin was coadministered with famotidine. Changes in pharmacokinetics of 5‐hydroxy saxagliptin generally paralleled the changes in saxagliptin. These pharmacokinetic changes were unlikely to be clinically meaningful. Coadministration of omeprazole did not affect saxagliptin Cmax or AUC. Saxagliptin in combination with these medicines resulted in no unexpected safety or tolerability findings in these healthy subjects. No dose adjustment of saxagliptin or separation in the time of saxagliptin dosing is necessary with medicines that raise gastric pH when coadministered with saxagliptin.

01 Jan 2017·Pharmaceutical BiologyQ3 · MEDICINE

Anti - Helicobacter pylori and antiulcerogenic activity of Aframomum pruinosum seeds on indomethacin-induced gastric ulcer in rats

Q3 · MEDICINE

ArticleOA

Author: Eyoum Bille, Bertrand ; Nguepi, Eveline ; Nanfack Nana, Blandine ; Kouitcheu Mabeku, Laure Brigitte ; Tchuenteu Tchuenguem, Roland

CONTEXTPeptic ulcer is one of the most common diseases affecting mankind. Although there are many products used for its treatment, most of these products produce severe adverse reactions requiring the search for novel compounds. Some Afromomum species are used traditionally to cure acute gastritis.OBJECTIVETo evaluate the antiulcer activity of the methanol extract of Aframomum pruinosum Gagnepain (Zingiberaceae) seeds against two major etiologic agents of peptic ulcer disease; Helicobacter pylori and non-steroidal anti-inflammatory drugs.MATERIALS AND METHODSThe anti-Helicobacter activity of A. pruinosum was evaluated using the broth microdilution method. After oral administration of indomethacin (5 mg/kg) for 5 consecutive days, gastric ulcerated animals were divided into control group and five other groups: three groups that recieved respectively 125, 250 and 500 mg/kg of plant extract, the fourth group received Maalox (50 mg/kg) and the fifth group, Misoprostol (100 μg/kg), respectively, for 5 days. Ulcer areas, gastric mucus content and nitric oxide gastric levels of animals were assessed 24 h after this treatment.RESULTSA. pruinosum extract shows a moderate anti-Helicobacter activity with an MIC value of 128 μg/mL. A. pruinosum extract, like Misoprostol and Maalox, markedly reduces the % of ulcerated area from 8.15 ± 0.33 to 1.71 ± 0.44% (500 mg/kg). It also increased significantly mucus and NO gastric production with respective values of 4.44 ± 1.35 and 965.81 ± 106.74 μmol/g (500 mg/kg).DISCUSSION AND CONCLUSIONThese findings suggest that A. pruinosum methanol extract possesses antiulcer properties as ascertained by the comparative decreases in ulcer areas, increase of mucus and NO gastric production.

100 Deals associated with Aluminum hydroxide/Magnesium Hydroxide

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Duodenal Ulcer	JP	Sanofi KK	03 Mar 1992
Gastritis	JP	Sanofi KK	03 Mar 1992
Stomach Ulcer	JP	Sanofi KK	03 Mar 1992

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Pneumococcal	Discovery	GB	Genocea Biosciences, Inc.	30 Sep 2014
Malaria	Discovery	NL	Institut Pasteur	31 Oct 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00444275 (MAESTRO, CTgov)	Phase 4	Gastroesophageal Reflux	3,029	esomeprazole (Nexium®) (Esomeprazole 20 mg Once Daily (Maintenance Phase))	fxieraqspb(hxsnlpodeg) = wsgoptfrxu gcfwehztua (ovrwyhgidq, aaneiocvpe - czifwklylj) View more	-	11 Dec 2012
				esomeprazole (Nexium®) (Esomeprazole 20 mg on Demand (Maintenance Phase))	fxieraqspb(hxsnlpodeg) = bvstlbgxaw gcfwehztua (ovrwyhgidq, xcjcqazxyu - kdmhtatfqo) View more
NCT01281501 (CTgov)	Phase 4	Dyspepsia \| Acute Pain	87	Hyoscine butylbromide+Oral antacid+Normal Saline (Conventional)	xnlvwwgadr(myesphoyuq) = fbekkxqxpl ozwpnxxpfr (lgbndnlpsf, xweskeinrg - qezpsxnbfi) View more	-	27 Jul 2012
				Hyoscine butylbromide+Oral antacid+Pantoprazole (Pantoprazole)	xnlvwwgadr(myesphoyuq) = ppgswamlzu ozwpnxxpfr (lgbndnlpsf, encgvjuctv - elimsmserc) View more