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Trial record 67 of 1357 for:    Area Under Curve AND tablet

Scintigraphy Study to Compare the Antireflux Activity of the 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: NCT03065816
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.

Secondary Objective:

Safety: assessment of the clinical safety of Z0063 versus 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 total study duration per subject is 37 days including a screening period up to 21 days, a wash-out period of 4-7 days and a follow-up of 4-7 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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 Scintigraphy, the Antireflux 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 Subjects
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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. Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach [ Time Frame: 4 hours after IMP administration ]

Secondary Outcome Measures :
  1. Pharmacodynamics: AUC of meal percentage retention in the whole stomach [ Time Frame: 4 hours after IMP administration ]


Information from the National Library of Medicine

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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/m^2, inclusive.
  • Certified as healthy by a comprehensive clinical assessment.
  • Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
  • Subject has to be willing to eat the standard radiolabelled meal (eggs on toasts and orange juice).

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 of more than 450 mL within 3 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 subject in the exclusion period of a previous study: participation in a new chemical entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
  • 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 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/or swallowing.
  • Participation in a study in which radioisotopes were administered or in which subject was exposed to any radiation other than normal background radiation within the 12 months before the screening visit.
  • Any intake of aluminum 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): NCT03065816


Locations
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United Kingdom
Investigational site 826001
Merthyr Tydfil, United Kingdom, CF48 4dr
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: NCT03065816     History of Changes
Other Study ID Numbers: PDY14363
2015-000764-34 ( EudraCT Number )
U1111-1182-1864 ( Other Identifier: UTN )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: June 15, 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
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Almagate
Aluminum Hydroxide
Magnesium Hydroxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs