drugset / Trial / NCT02758912

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

NCT02758912 ↗

Phase 4 Completed 32 enrolled Burnasyan Federal Medical Biophysical Center
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject trimethylhydrazinium propionate dihydrate Unknown 1 g Oral
Subject trimethylhydrazinium propionate dihydrate Unknown 2 g Oral

Indications