The Gastric Residence Time (GRT) of Soctec Capsule After a Standardized Breakfast

Study Overview
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Brief Summary
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The primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer compared to literature values reported for a simliar sized capsule.

Official Title
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Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)

Conditions
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Healthy

Intervention / Treatment
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* Device: Soctec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male HS, aged between 18 and 50 years. Subjects must be in a good health and have BMI between 19 and 25 kg/m2. Subjects must be able to read, understand and sign the written informed consent. Subjects must be willing and able to comply with study requirements. Exclusion Criteria: History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse. Subjects with a history of HIV, hepatitis B or hepatitis C. Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors and non-steroidal anti-inflammatory drugs. Prior abdominal surgery other than uncomplicated appendectomy or hernia repair. Subject with claustrophobia (fear of small spaces). Presence of implants, devices or metallic foreign bodies that might interact with the MRI Participation in another investigational study where the study drug was received within 90 days prior to the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soctec / Capsule<br>HS intakes one(1) Soctec Capsule after standardized breakfast | Device: Soctec<br>* Gastroretentive Drug Delivery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast. |  | MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroretentive System, Gastric Retention Time (GRT), capsule, Soctec, Gastroenterology