NCT03028285

Study of Safety and Tolerability of UNIFUZOL (Solution for Infusions) in Healthy Volunteers

Open Randomized Study of the Safety, Tolerability, and Pharmacokinetic Parameters of UNIFUZOL® (Solution for Infusions, 1.4%, Manufactured by "NTFF"POLYSAN " Ltd.,Russia) in Healthy Volunteers at Different Rates of Administration (Phase I)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DRUG	arginine sodium succinate	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.

Timeline

• Start date: 2016-07-15
• Primary completion: 2017-01-19
• Completion: 2017-01-26
• First posted: 2017-01-23
• Last updated: 2020-07-14

Locations

2 sites across 1 country: Russia