BCD-220-1 "An open-label, randomized, crossover bioequivalence study of BCD-220 compared to the reference drug in healthy male volunteers following single-dose administration under fasting conditions".
During the course of the BCD-220-1 clinical trial will investigate the bioequivalence of the investigational drug BCD-220 following a single oral dose administration under fasting conditions in healthy male subjects who:
Diagnosed as “healthy”, based on the conventional clinical, laboratory and imaging methods of examination, conducted during the screening period1, according to the Clinical Investigator’s opinion, as well as medical history.
Aged 18–45 years inclusive at the time of signing the informed consent form.
Have a body weight of 50 kg or more.
Have a body mass index ranging from 18.5 to 30.0 kg/m2 , inclusive, at screening.
Have no burdened allergic history.
Agree to use reliable contraception and refrain from sperm donation or fathering a child from the start of the clinical trial participation until 3 months after the last dose of the investigational drug.
The clinical trial of BCD-220-1 is being conducted at the study center in St. Petersburg.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Clinical Investigator and/or Treating Physician.
Clinical Trial Authorization No. 588 dated December 11, 2024 of the Ministry of Health of the Russian Federation and the information about approved study center in the territory of the Russian Federation have been published in the State Register of Medicines.
Screening is a specific time period aimed at assessing a subject’s eligibility in a clinical trial according to the inclusion/non-inclusion criteria based on the diagnostic procedures and medical specialist consultations.