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TP0501 - Pharmaco-Scintigraphic-Study

NCT02306772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-12-03

No results posted yet for this study

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

Interventions

DRUG

TP05 Coating A

One radio-labelled tablet given to subjects

DRUG

TP05 Coating B

One radio-labelled tablet given to subjects

Sponsors & Collaborators

  • Tillotts Pharma AG

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-02-29
Completion
2012-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306772 on ClinicalTrials.gov