Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
- Registration Number
- NCT03065816
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 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 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
- Primary Outcome Measures
Name Time Method Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach 4 hours after IMP administration
- Secondary Outcome Measures
Name Time Method Pharmacodynamics: AUC of meal percentage retention in the whole stomach 4 hours after IMP administration
Trial Locations
- Locations (1)
Investigational site 826001
🇬🇧Merthyr Tydfil, United Kingdom