Trials / Unknown
UnknownNCT02335515
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
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- SkyePharma AG · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Soctec | Gastroretentive Drug Delivery System |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2014-10-01
- Completion
- 2015-03-01
- First posted
- 2015-01-09
- Last updated
- 2015-01-09
Source: ClinicalTrials.gov record NCT02335515. Inclusion in this directory is not an endorsement.