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Be Part of Research - Trial Details - Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®
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Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

Completed

Open to: MALE

Age: 18.0 - 45.0

Ruddington

Medical Conditions

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


The primary objectives of the study are:

* To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations * To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation * Optional: To assess the intravenous pharmacokinetics of RhuDex following administration of an IV microtracer of \[14C\]RhuDex

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2011 Mar 2012

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Part 1:

Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose

The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions.




You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Quotient Clinical
    Ruddington
    Nottingham
    NG11 6JS


The study is sponsored by MediGene



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Read full details for Trial ID: NCT01500122
Last updated 20 June 2012

This page is to help you find out about a research study and if you may be able to take part

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