Gastroesophageal Reflux Disease
Conditions
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * Male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Normal vital signs, electrocardiogram (ECG) and laboratory parameters. * Subject has to accept a gastric probe.
Exclusion criteria
* Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation. * Blood donation, any volume, within 2 months before inclusion. * History or presence of drug or alcohol abuse. * Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * If female, pregnancy (defined as positive beta-human chorionic gonadotropin \[β-HCG\] blood test), breast-feeding. * Any medication (including St John's Wort) within 14 days before inclusion, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. * Any subject in the exclusion period of a previous study according to applicable regulations. * Any subject who cannot be contacted in case of emergency. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab). * Positive result on urine drug screen. * Positive alcohol breath test. * Known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal. * Any subject with difficulty in chewing and swallowing. * Any subject with strong gag reflex. * Any intake of aluminium and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 4-hour median pH | 4 hours after the IMP administration |
Countries
France
Outcome results
None listed