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

NCT02335515 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-01-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

Soctec

Gastroretentive Drug Delivery System

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • SkyePharma AG

    lead INDUSTRY

Principal Investigators

  • Karim Bagate, PhD · SkyePharma AG

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335515 on ClinicalTrials.gov