NCT03069963

PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The maximal total study duration per subject is 5 weeks and 1 day.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Z0063	Pharmaceutical form: chewable tablets Route of administration: oral
DRUG	Gaviscon	Pharmaceutical form: chewable tablets Route of administration: oral

Timeline

• Start date: 2017-02-24
• Primary completion: 2017-04-23
• Completion: 2017-04-23
• First posted: 2017-03-03
• Last updated: 2022-05-12

Locations

1 site across 1 country: France