Clinical Study of Medicinal Product Cardionat® Using in Health Athlete Volunteers (NCT02758912) | Clinical Trial Compass
CompletedPhase 4
Clinical Study of Medicinal Product Cardionat® Using in Health Athlete Volunteers
Russia32 participantsStarted 2016-11
Plain-language summary
The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.
The study consists of four steps:
* Step 1. Screening - selecting healthy volunteers for inclusion in the study;
* Step 2. Assignment in one of the study group, prescription of the study drug;
* Step 3. Samples collections for pharmacokinetic analysis;
* Step 4. Evaluation of pharmacokinetic data.
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion criteria
✓. Healthy volunteers of both sexes aged 18 to 35 years old, caucasians;
✓. At least 1st sports category among adults;
✓. Verified diagnosis "healthy" according to a detailed medical history, and according to standard clinical, laboratory and instrumental methods of examination;
✓. BMI should be between 18.5 to 30 kg / m2;
✓. Signed Volunteer information sheet with the Informed consent form;
✓. Agreement of volunteer to use adequate methods of contraception (contraceptive reliability over 90%: the cervical cap with spermicide, diaphragm with spermicide, condoms, intrauterine devices), or total abstinence from sexual activity for the period of the study:
✓. Allergy in the past;
✓. Drug intolerance, hypersensitivity to any component of the study drug;
Exclusion criteria
✕. Unexpected and previously unknown adverse reactions (if it is related to support volunteer's health);
✕. Occurrence of SAEs;
✕. Acute diseases or conditions that are not SAEs, but according to researchers opinion, require exclusion of volunteers from the study;
✕. Decision to volunteer to withdraw from the study;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: 3 weeks after assignment of all eligible volunteers to one of the study groups (day 22th)
Trial details
NCT IDNCT02758912
SponsorBurnasyan Federal Medical Biophysical Center