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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02335515

Enrollment

Registered

2015-01-09

Start date

2014-09-30

Completion date

2015-03-31

Last updated

2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Gastroretentive System, Gastric Retention Time (GRT), capsule, Soctec, Gastroenterology

Brief summary

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.

Interventions

DEVICESoctec

Gastroretentive Drug Delivery System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026