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 range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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