05.Mar.2012

OCT has been awarded a Bioequivalence (BE) trial from a leading pharmaceutical company

OCT has been awarded  a Bioequivalence (BE) trial from a leading pharmaceutical company. OCT has won a bidding for a conduct of a pharmacokinetic (PK) study for a multinational corporation. The company is a leading manufacturer of healthcare products worldwide.

OCT has been awarded  a Bioequivalence (BE) trial from a leading pharmaceutical company

OCT has won a bidding for a conduct of a pharmacokinetic (PK) study for a multinational corporation. The company is a leading manufacturer of healthcare products worldwide.

This will be a full-service project, including Data Management and Statistics support. OCT will be responsible for writing the study protocol and investigator’s brochure, informed consent and CRF in accordance with ICH-GCP, Russian and international standards requirements so that the clinical data received could be used for product registration in Russia and for product submission in foreign countries as well.  OCT will perform project management and administration, regulatory and logistics support, clinical monitoring, pharmacovigilance, and final integrated report preparation, including Bioequivalency (BE) report for product registration dossier.

The project is an open-label, 2-way crossover, randomized, single dose, single centre trial in healthy volunteers to compare the bioavailability of nonsteroidal anti-inflammatory drug with the similar product registered in another dose.

26 healthy volunteers will be enrolled and treated at one site which is a leading accredited institution in the country for conducting Phase I studies in Russia. OCT has worked with the site within several projects. The Phase I Unit staff is trained in ICH-GCP, international and local standards and will be trained by OCT in accordance with the study protocol to ensure high quality of clinical trials’ conduct. They have a wide experience in clinical trials in Phase I with healthy volunteers and have a database of more than 500 potential subjects. The Phase I Unit is audited by different Sponsors and regulatory authorities on routine basis.

A GLP-compliant bioanalytical laboratory will be included into the project for pharmacokinetics (PK) sample analysis.

For OCT pain products studies are not new. OCT has solid experience in pain studies with different pain models. Please see below examples illustrating OCT clinical trials experience in pain:

  • Sore throat phase II study, including 60 patients at 3 sites in Russia. OCT has provided full service support including Clinical Data Management (DM) and Statistics. Study drug was chewing tablets with localized anti-inflammatory effect;
  • A phase III study in patients undergoing a major orthopedic surgery, including 45 patients at 6 sites  in Russia. The study was a rescue study, the study conducted by OCT. Study drug was NSAID with pain-relieving effect administered through intravenous injection
  • A phase III study in patients with abdominal pain, including 110 patients at 2 sites in Russia. OCT has provided a  full service support. Study drug-antispasmodics.
A phase II study in patients with bone metastases. Study drug –monoclonal antibody directed against nerve growth factor (NGF), developed for use in moderate to severe chronic pain conditions and administered orally (tablets).