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

NCT02758912 | Completed Phase 4 DMC

• 1 other identifier: RU-FMBC-04-04-16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Not Specified as Hemorrhage or Infarction; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Data collected and assessed for each AE include type, duration, relationship to study drug, action taken and the outcome of the event. Registration of SAEs begins right after the first dose of study drug during the whole course of treatment.

  3 weeks after assignment of all eligible volunteers to one of the study groups (day 22th)

Secondary Outcomes (10)

• Cardionat® levels in blood

  following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151

• Cardionat® levels in urine

  following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151

• Exercise load duration (Tel)

  following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151

• Time of onset of aerobic threshold (Tat)

  following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151

• Time of onset of the anaerobic threshold (Tant)

  following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151

Study Arms (2)

arm 1, Cardionat®

EXPERIMENTAL

oral intake of study drug capsules at a dose of 1 g per day for 3 weeks.

Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg

arm 2, Cardionat®

EXPERIMENTAL

oral intake of study drug capsules at a dose of 2 g per day for 3 weeks.

Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg

Interventions

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

arm 1, Cardionat®; arm 2, Cardionat®

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• For women during the whole period from 30 days prior to the signing a Volunteer's information sheet with Informed consent form to 30 days after completion of study participation; in the period from the date of signing the Informed consent up to 30 days after completion of study participation barrier method of contraception should be used, if it is not the main method;
• For men during the whole period from signing a Volunteer's information sheet with the Informed consent form and until the completion of the study barrier method of contraception should be used.
• Allergy in the past;
• Drug intolerance, hypersensitivity to any component of the study drug;
• Chronic cardiovascular, bronchopulmonary, endocrine or nervous systems diseases (including psychiatric disorders), and diseases of the gastrointestinal tract (GIT), liver, kidney, blood disorders, surgical interventions on the gastrointestinal tract (except appendectomy);
• Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency;
• Poor developed superficial veins of the forearm;
• Acute infectious, non-infectious and allergic diseases in less than 4 weeks prior to Visit 1 (screening);
• Positive blood test for HIV, syphilis, hepatitis B and C;

You may not qualify if:

• Unexpected and previously unknown adverse reactions (if it is related to support volunteer's health);
• Occurrence of SAEs;
• Decision to volunteer to withdraw from the study;
• Violation by volunteer of prescribed regimen and violation of research restrictions (by the decision of the investigator);
• Investigator's decision to exclude the volunteer from the study

Sponsors & Collaborators

• Burnasyan Federal Medical Biophysical Center: lead

Study Sites (1)

Federal State Budget Institution "State Scientific Center of Russian Federation - the Federal Medical Biophysical Center named after A I Burnazyan" (FSBI SSC FMBC name AI Burnazyan FMBA of Russia)

Moscow, 123098, Russia

Location

Related Publications (1)

• Rabin O, Uiba V, Miroshnikova Y, Zabelin M, Samoylov A, Karkischenko V, Semyonov S, Astrelina T, Razinkin S. Meldonium long-term excretion period and pharmacokinetics in blood and urine of healthy athlete volunteers. Drug Test Anal. 2019 Apr;11(4):554-566. doi: 10.1002/dta.2521. Epub 2018 Nov 12.

  PMID: 30328291 BACKGROUND

MeSH Terms

Conditions

Stroke; Angina Pectoris

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 3, 2016
• Study Start: November 1, 2016
• Primary Completion: September 25, 2019
• Study Completion: October 25, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

RU (1)