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OCT Clinical has obtained approval for a phase I study from the Ministry of Health of Russia in less than a month without objections.
This is an open, randomized, three-stage comparative study of the pharmacokinetics, pharmacodynamics and safety of DES (esomeprazole, 20 mg and 40 mg modified-release capsules) vs. active comparator for a single and multiple use by men and women aged 18-45 years.
The treatment period is devided into several stages. The first stage includes 3 periods with a single-dose use within each, during the second and third stages the drug is to be taken in multiple doses for 5 days.
The overall duration of the clinical part is 3.5-4 months. At the moment, the recruitment target has been reached only for the 1st period with 40 volunteers enrolled (all randomized within 1 day). Recruitment for the following stages is due next once the first one is complete.
“There are several challenges within this study: numerous procedures including blood sampling for the PK analysis, 24-hour pH-metry for some of the volunteers during the 2nd and 3d stages, as well as a big number of volunteers. Nevertheless, our team managed to randomize the first batch of patients within 1 day and receive a CTA within less than a month without a single objection.” commented Irina Petrova, OCT Clinical Director of Clinical Operations.
Within this project, OCT Clinical team is responsible for the entire project, including regulatory support, monitoring, logistics, pharmaceutical safety, project management, quality assurance.
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