Overview

TP0501 - Pharmaco-Scintigraphic-Study

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Tillotts Pharma AG
Treatments:
Mesalamine