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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

NCT05505097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Valenta Pharm JSC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2022-12-19
Completion
2022-12-19

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505097 on ClinicalTrials.gov