RF Ministry of Healthcare Approves BelSU to Clinically Test a New Drug

The BelSU Clinical and Preclinical Studies Centre is starting clinical research of a new MRI contrast agent.

This September, the BelSU Clinical and Preclinical Studies Centre will begin first clinical research of Dipentast – a sodium-gadopentate-based drug of the group of contrast media used to improve the visibility of internal body structures in magnetic resonance imaging (MRI).

According to Professor Mikhail Pokrovsky, Head of the BelSU Clinical and Preclinical Studies Centre, they are licensed to conductan open, non-comparative study of how it is absorbed, distributed, metabolized, and excreted. The Centre will also evaluate its efficacy, side effects, and safety.

Prepared as 10% solution for injection, the drug will be tested on healthy human volunteers by intravenous administration of one dose of 0.2 ml per kg body weight.

The Centre will estimate the following values:

- C_max = maximum concentration observed,

- AUC (0-24)and AUC (0-t) = the ratio of the area under the concentration time curve during a time period,

- T½ = elimination half-life,

- MRT = mean residence time.

The Ministry of Healthcare of the Russian Federation approved Belgorod National Research University approved for conducting clinical research in April, 2014. The University possesses a high productive pharmacokinetic laboratory with magnetic particle based sample preparation equipment which provides a strong competitive advantage for working in the constantly evolving pharma clinical trial services industry.