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.
The maximal total study duration per subject is 5 weeks and 1 day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Investigational Site Number 2500001
Gières, France
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
Time frame: 4 hours after the investigational medicinal product (IMP) administration
Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose
Time frame: 4 hours after the IMP administration
4-hour median pH
Time frame: 4 hours after the IMP administration
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