NCT02758912

Clinical Study of Medicinal Product Cardionat® Using in Health Athlete Volunteers

Open-label Clinical Pharmacokinetic Study of Cardionat®, Capsules 250 mg (JSC Nizhpharm, Russia) Using in Health Athlete Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Burnasyan Federal Medical Biophysical Center · Other Government
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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: * Group 1: intake of study medication capsules orally at a dose of 1 g per day for 3 weeks - 14 volunteers (7 males and 7 females); * Group 2: intake of study medication capsules at a dose of 2 g per day for 3 weeks - 14 volunteers (7 males and 7 females). Study results will be published in "Drug Testing and Analysis" journal

Conditions

• Stroke, Not Specified as Hemorrhage or Infarction
• Angina Pectoris

Interventions

Type	Name	Description
DRUG	оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-09-25
• Completion: 2019-10-25
• First posted: 2016-05-03
• Last updated: 2020-04-10

Locations

1 site across 1 country: Russia