NCT05505097

Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers

Open Randomized Comparative Crossover Study of the Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study aimed for: 1. To study the safety of the drug Dioxidin, solution for topical and external use; 2. To determine the concentrations of the active substance of the studied drugs Dioxidin, solution for topical and external use, and Dioxidin, solution for infusion and external use in discrete time intervals; 3. To study pharmacokinetics of the drug Dioxidin, solution for topical and external application; 4. To determine the absolute bioavailability of the drug Dioxidine, solution for topical and external use.

Conditions

• Infections

Interventions

Type	Name	Description
DRUG	Hydroxymethylquinoxalindioxyde	Dioxidin (Hydroxymethylquinoxalindioxyde), solution for topical and external use, 0.25 mg/ml, applied as: A - single rinsing of the oropharynx with 15.0 ml of the drug solution for at least 30 seconds B - single irrigation of the oropharynx by spraying the preparation 4 times with a spray nozzle C - irrigation of the skin on the back by spraying the preparation 4 times from a distance of 10 cm on 1% of the body surface using a spray nozzle and exposing the solution for 30 minutes or D - Dioxidin (Hydroxymethylquinoxalindioxyde), solution for infusion and external application, 5 mg/ml, single intravenous 5 mg/ml in 1 ml

Timeline

• Start date: 2022-05-04
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2022-08-17
• Last updated: 2023-08-21

Locations

1 site across 1 country: Russia