OCT has won a tender for conducting an open-label randomized single-center three-period single-dose bioequivalence study in healthy volunteers of a fixed combination investigational drug with the appropriate reference products.
The study will be performed in accordance with GOST R 52379-2005 “Good clinical practice”, Federal Law No. 61-FZ of 12.04.2010 “On circulation of medicines”, Bioequivalence Assessment of Medical Drugs Guidelines of 2008, and other applicable legislation.
The investigational product is a new unique painkiller combination of ibuprofen and paracetamol. The drug is indicated for the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. This product is especially suitable for pain which requires stronger analgesia than it is reached within monotherapy by means of ibuprofen or paracetamol.
The study drug is formulated using a unique patented technology, by means of which the active ingredients are dissolved rapidly in the stomach and are able to deliver a “combination effect” of two actives with opposing dissolution profiles.
The study will be placed at the leading certified Phase I investigational center. 28 healthy volunteers will be randomized within the PK trial.
For OCT this will be a full-service project including medical writing, regulatory and logistics support, project management and administration, quality assurance, clinical monitoring, pharmacovigilance, data management and biostatistics, final BE and statistical report preparation.
The leading Russian analytical laboratory will be involved in this bioequivalence study . The special analytical method will be developed, validated, and used in the trial.
OCT will be glad to support its Client within the clinical study, which is aimed to register the generic product in Russia.
We are proud that this is the second project requested by the same Sponsor – one of the leading UK life science companies.