Trials / Completed
CompletedNCT02306798
TP0502-B-Pharmaco-Scintigraphic-Study
An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profile
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Tillotts Pharma AG · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine \[9\] subjects will be evaluated. The subjects will receive one \[1\] radio-labelled tablet after a high fat and a rich in calories breakfast.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TP05 | One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-11-01
- Completion
- 2013-12-01
- First posted
- 2014-12-03
- Last updated
- 2014-12-04
Source: ClinicalTrials.gov record NCT02306798. Inclusion in this directory is not an endorsement.