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

NCT02758912 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-04-10

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Burnasyan Federal Medical Biophysical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-09-25
Completion
2019-10-25

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758912 on ClinicalTrials.gov