Study of Safety and Tolerability of UNIFUZOL (Solution for Infusions) in Healthy Volunteers
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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).
    

Intervention name(s): arginine sodium succinate
Intervention type(s): Drug
Intervention description(s): Healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at 3 different combinations of dose and infusion rate under the close monitoring of vital signs and other safety parameters.
Other intervention name(s): Unifusol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: succinate; arginine; vasodilation; peripheral vascular disease