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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03069963
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

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
Gastroesophageal Reflux Disease Drug: Z0063 Drug: Gaviscon Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 24, 2017
Actual Primary Completion Date : April 23, 2017
Actual Study Completion Date : April 23, 2017

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





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 4-hour median pH [ Time Frame: 4 hours after the IMP administration ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069963


Locations
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France
Investigational Site Number 2500001
Gieres, France, 38610
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03069963     History of Changes
Other Study ID Numbers: PDY14362
2015-000763-13 ( EudraCT Number )
U1111-1183-5042 ( Other Identifier: UTN )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antacids
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Almagate
Aluminum Hydroxide
Magnesium Hydroxide
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs