NCT03065816

Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The total study duration per subject is 37 days including a screening period up to 21 days, a wash-out period of 4-7 days and a follow-up of 4-7 days.

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: 2017-02-09
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2017-02-28
• Last updated: 2022-04-25

Locations

1 site across 1 country: United Kingdom