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TP0502-Pharmaco-Scintigraphic-Study and Amendment

Ulcerative Colitis Clinical Trial

Official title:
An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment)

Clinical Trial 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 and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively.

Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H.

In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02306785
Study type Interventional
Source Tillotts Pharma AG
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date June 2013
View Details
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