Clinical Trials Logo

Clinical Trial Summary

Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers.


Clinical Trial Description

Unifuzol, solution for infusions,("NTFF POLYSAN" Ltd., Russia) contains succinic acid and arginine as active ingredients; it has demonstrated cardioprotective, anti-ischemic, endothelial protective and fibrinolytic activity in pre-clinical studies and is considered for clinical trials in peripheral vascular disease.

The primary aim of the present Phase I study is to assess safety and tolerability of Unifusol (1.4% solution for infusions) at different infusion rates in healthy volunteers.

Study objectives:

1. Assess the safety parameters (vital signs, the incidence of AEs, SAEs, laboratory abnormalities) during infusion of Unifusol (1.4% solution for infusions) in healthy volunteers at different infusion rates.

- administration of a single infusion of 250 ml at a rate of 3 ml / min.

- administration of a single infusion of 250 ml at a rate of 4.5 ml / min

- administration of a single infusion of 500 ml at a rate of 4.5 ml / min

2. Study the pharmacokinetics parameters of the active components of the Unifusol (succinic acid and arginine) in healthy volunteers after single infusion at a dose of 250 ml at a rate of 4.5 ml / min.

Study methods:

1. Determination of pharmacokinetic parameters of succinic acid administered at a single Unifusol infusion dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);

2. Determination of pharmacokinetic parameters of arginine after a single Unifusol infusion at a dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);

3. Determination of individual variations of the pharmacokinetic parameters of succinic acid and arginine in healthy volunteers;

4. Identification of significant gender differences in the pharmacokinetics of the active ingredients of Unifusol (succinic acid and arginine) in healthy volunteers;

5. Determination of the number of compartments in the pharmacokinetic model which will be most appropriate to the measured concentrations after a single infusion (single-chamber, two-chamber or three-chamber pharmacokinetic model). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03028285
Study type Interventional
Source POLYSAN Scientific & Technological Pharmaceutical Company
Contact
Status Completed
Phase Phase 1
Start date July 15, 2016
Completion date January 26, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Completed NCT02271529 - Zilver PTX Delivery System N/A
Recruiting NCT02054871 - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Completed NCT01355406 - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Active, not recruiting NCT03241459 - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon N/A
Active, not recruiting NCT01661231 - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe N/A
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01444378 - Absolute Pro® MOMENTUM™ N/A
Completed NCT00753337 - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study N/A
Completed NCT00593385 - Atrium iCAST Iliac Stent Pivotal Study N/A
Completed NCT00538226 - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg Phase 1
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Completed NCT00392509 - ALD-301 for Critical Limb Ischemia, Randomized Trial Phase 1/Phase 2