PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
- Registration Number
- NCT03069963
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 (Z0063 to Gaviscon) Z0063 The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose Sequence 1 (Z0063 to Gaviscon) Gaviscon The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose Sequence 2 (Gaviscon to Z0063) Z0063 The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose Sequence 2 (Gaviscon to Z0063) Gaviscon The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose
- Primary Outcome Measures
Name Time Method 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 4 hours after the investigational medicinal product (IMP) administration
- Secondary Outcome Measures
Name Time Method 4-hour median pH 4 hours after the 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 4 hours after the IMP administration
Trial Locations
- Locations (1)
Investigational Site Number 2500001
🇫🇷Gieres, France