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TP0502-B-Pharmaco-Scintigraphic-Study

NCT02306798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-12-04

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 will be evaluated. The subjects will receive one \[1\] radio-labelled tablet after a high fat and a rich in calories breakfast.

Conditions

Interventions

DRUG

TP05

One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast

Sponsors & Collaborators

  • Tillotts Pharma AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-12-31

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Entities

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 NCT02306798 on ClinicalTrials.gov