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About
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:
Full description
Cardionat is a structural analogue of gamma-butyrobetaine - a substance that is in every cell of the human body.
Under extra strain conditions cardionat restores the balance between oxygen delivery to the cell and cellular oxygen demand. Cardionat clears the intracellular accumulation of toxic metabolic products, protecting them from damage; also it has a general tonic effect. As a result of its use of the body acquires the ability to withstand stress and to quickly restore energy reserves. Because of these properties cardionat used to treat a variety of disorders of the cardiovascular system, disorders of blood supply to the brain, as well as to improve physical and mental performance. Synthesis of gamma-butyrobetaine, which has vasodilating properties, is highly increased as a result of reducing the concentration of carnitine.
In the case of acute ischemic myocardial injury cardionat slows the formation of necrotic areas, shortens the rehabilitation period.
In heart failure it increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders it improves blood circulation in the ischemic areas; it promotes blood redistribution increasing supply of the ischemic areas. It is effective in the case of vascular and dystrophic pathology of the ocular fundus. The drug eliminates functional disturbances of the nervous system in patients with chronic alcoholism during abstinence syndrome.
Pharmacokinetics After oral administration, the drug is rapidly absorbed. Bioavailability is 78%. The maximum plasma concentration is reached 1-2 hours after oral ingestion. The drug is metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life after oral intake is dose-dependent, and is usually 3 to 6 hours.
Indications for use:
As a part of combination treatment of coronary heart disease (angina, myocardial infarction), congestive heart failure and dyshormonal cardiomyopathy, as well as part of combination treatment of acute and chronic cerebrovascular disorders (stroke and cerebrovascular insufficiency).
Reduced working capacity; physical stress, including physical stress in athletes.
Abstinence syndrome in chronic alcohol abusers (in combination with specific alcohol abuse therapy).
In this study, volunteers will receive study medication in the form of oral capsules 250 mg.
The study drug will be applied as follows:
Study results will be published in "Drug Testing and Analysis" journal
Enrollment
Sex
Ages
Volunteers
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:
Non - inclusion criteria:
Exclusion criteria
Primary purpose
Allocation
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32 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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