PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069963
• Other study ID #: PDY14362
• Secondary ID: 2015-000763-13U1
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2017
• Est. completion date: April 23, 2017

Study information

• Verified date: June 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The maximal total study duration per subject is 5 weeks and 1 day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 23, 2017
• Est. primary completion date: April 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 [ß-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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Z0063
Pharmaceutical form: chewable tablets Route of administration: oral
• Gaviscon
Pharmaceutical form: chewable tablets Route of administration: oral

Locations

Country	Name	City	State
France	Investigational Site Number 2500001	Gieres

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	4-hour median pH		4 hours after the IMP administration