The primary objective
A comparison of the equivalence of two drugs – the test and the original – in healthy people (volunteers).
Generally, bioequivalence studies have a comparative cross-over design. In accordance with such design all volunteers participating in the study are divided into two groups — test drug and reference drug. Volunteers of both groups administer the test drug and the reference drug, respectively. According to the study protocol, volunteers blood samples are taken at regular intervals, and the active substance of the drug and / or its metabolites are analyzed. When the drug is completely eliminated from the body, they are changed over – and the one who administered the test drug starts to administer the reference drug and vice versa.
The formation and further comparison of the concentration / time dependences of both groups will allow to draw conclusion about the bioequivalence of the drugs.
Who takes part in Bioequivalence studies?
Healthy volunteers may participate in bioequivalence studies, with the exception of some cases (for example, a study of antineoplastic drugs).
Bioequivalence studies can be conducted on citizens of both sexes who fully meet the requirement of being “healthy” from a clinical and laboratory point of view.
Who is forbidden to participate in studies?
The main categories of volunteers who are prohibited to participate in bioequivalence studies:
- people with mental disorders;
- people with HIV infection in the body;
- women during pregnancy and lactation;
- military personnel.
When conducting bioequivalence studies, the Sponsor provides life and health insurance for volunteers, as well as insurance for investigators (doctors) against medical errors. For participation in bioequivalence studies, volunteers receive payment.