drugset / Trial / 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

NCT05505097

Phase 1 Completed 16 enrolled Valenta Pharm JSC
RandomizedCrossoverOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject DIOXYDINE Small molecule 0.25 mg/ml Topical
Subject DIOXYDINE Small molecule 5 mg/ml Topical

Indications