- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069963
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Gieres, France, 38610
- Investigational Site Number 2500001
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Pharmaceutical form: chewable tablets Route of administration: oral 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
|
Pharmaceutical form: chewable tablets Route of administration: oral Pharmaceutical form: chewable tablets Route of administration: oral |
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 4 hours after the investigational medicinal product (IMP) administration
|
4 hours after the investigational medicinal product (IMP) administration
|
Secondary Outcome Measures
Outcome 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
Time Frame: 4 hours after the IMP administration
|
4 hours after the IMP administration
|
4-hour median pH
Time Frame: 4 hours after the IMP administration
|
4 hours after the IMP administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastroesophageal Reflux
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Antacids
- Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Other Study ID Numbers
- PDY14362
- 2015-000763-13 (EudraCT Number)
- U1111-1183-5042 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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