NCT02306772

TP0501 - 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 Profiles of Two Different Formulations.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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 per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	TP05 Coating A	One radio-labelled tablet given to subjects
DRUG	TP05 Coating B	One radio-labelled tablet given to subjects

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2014-12-03
• Last updated: 2014-12-03