PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
The maximal total study duration per subject is 5 weeks and 1 day.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Sequence 1 (Z0063 to Gaviscon) The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose |
Drug: Z0063
Pharmaceutical form: chewable tablets
Route of administration: oral
Drug: Gaviscon
Pharmaceutical form: chewable tablets
Route of administration: oral
|
Experimental: Sequence 2 (Gaviscon to Z0063) The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose |
Drug: Z0063
Pharmaceutical form: chewable tablets
Route of administration: oral
Drug: Gaviscon
Pharmaceutical form: chewable tablets
Route of administration: oral
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
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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.
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History or presence of drug or alcohol abuse.
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Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
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If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
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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.
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Any subject in the exclusion period of a previous study according to applicable regulations.
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Any subject who cannot be contacted in case of emergency.
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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).
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Positive result on urine drug screen.
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Positive alcohol breath test.
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Known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal.
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Any subject with difficulty in chewing and swallowing.
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Any subject with strong gag reflex.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigational Site Number 2500001 | Gieres | France | 38610 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PDY14362
- 2015-000763-13
- U1111-1183-5042