Delving into the Latest Updates on Sodium Alginate/Calcium Carbonate/Sodium Hydrogen Carbonate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Action

modulators

Mechanism

Bone development modulators

Therapeutic Areas

Digestive System DisordersMouth and Tooth DiseasesOtorhinolaryngologic Diseases

Active Indication-

Inactive Indication

Gastroesophageal Reflux

Originator Organization

Sanofi

Active Organization-

Inactive Organization

Sanofi

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC15H18ClN3O

InChIKeyUFNOUKDBUJZYDE-UHFFFAOYSA-N

CAS Registry94361-06-5

View All Structures (3)

A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject

Primary Objective:
Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.

Start Date24 Feb 2017

Sponsor / Collaborator

Sanofi

NCT03065816

/ CompletedPhase 1

A Randomized, Open-label, 2-Treatment Crossover Study to Compare by Scintigraphy, the Antireflux Activity of the To-be-Registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate) Chewable Tablets Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subjects

Primary Objective:
Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in healthy adult subjects.

Start Date09 Feb 2017

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Sodium Alginate/Calcium Carbonate/Sodium Hydrogen Carbonate

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100 Translational Medicine associated with Sodium Alginate/Calcium Carbonate/Sodium Hydrogen Carbonate

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100 Patents (Medical) associated with Sodium Alginate/Calcium Carbonate/Sodium Hydrogen Carbonate

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100 Deals associated with Sodium Alginate/Calcium Carbonate/Sodium Hydrogen Carbonate

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