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

NCT ID: NCT05505097

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2022-12-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ABCD-sequence

Hydroxymethylquinoxalindioxyde administration in a sequence A-B-C-D during the corresponding study periods 1, 2, 3, and 4

Group Type: OTHER

Hydroxymethylquinoxalindioxyde

Intervention Type: DRUG

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

BCDA-sequence

Hydroxymethylquinoxalindioxyde administration in a sequence B-C-D-A during the corresponding study periods 1, 2, 3, and 4

Group Type: OTHER

Hydroxymethylquinoxalindioxyde

Intervention Type: DRUG

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

CDAB-sequence

Hydroxymethylquinoxalindioxyde administration in a sequence C-D-A-B during the corresponding study periods 1, 2, 3, and 4

Group Type: OTHER

Hydroxymethylquinoxalindioxyde

Intervention Type: DRUG

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

DABC-sequence

Hydroxymethylquinoxalindioxyde administration in a sequence D-A-B-C during the corresponding study periods 1, 2, 3, and 4

Group Type: OTHER

Hydroxymethylquinoxalindioxyde

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Dioxidin

Eligibility Criteria

Inclusion Criteria

• Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study before any of the study procedures
• Age from 18 to 45 years (inclusive)
• Verified diagnosis "healthy" by standard clinical, laboratory, instrumental methods of examination
• Blood pressure level: systolic from 100 to 130 mmHg, diastolic from 60 to 90 mmHg (inclusive)
• Heart rate 60 to 90 beats per minute (inclusive)
• Body mass index (BMI) is 18.5 ≤ BMI ≤ 30.0 kg/m², with a body weight of ≥55 kg for men and ≥45 kg for women
• Volunteers must behave appropriately, coherent speech must be observed
• For women of childbearing potential, negative pregnancy test; consent of volunteers to either abstain from sexual intercourse or use a dual barrier method of contraception for the duration of study participation, beginning with the Screening Period, and for 3 weeks after study termination
• Ability to follow the daily routine and dietary regimen of the study protocol
• Ability to attend all scheduled appointments and stay at the Research Center for all Study Periods

Exclusion Criteria

• A history of allergic reactions
• A history of drug intolerance to the active and/or excipients in the study medications
• Inability to successfully perform oropharyngeal rinse test
• Any chronic illnesses
• History of gastrointestinal surgery (except appendectomy)
• Acute infectious diseases less than 4 weeks prior to screening
• Taking medications that significantly affect hemodynamics and medications that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening
• Regularly taking medications less than 2 weeks before screening and taking a single medication 7 days before screening
• Donating blood (450 mL of blood or plasma or more) less than 3 months before screening
• For women, the last intake of oral contraceptives at least 2 months prior to screening
• Pregnant and lactating women, and women and men of childbearing age who cannot or do not abstain from sexual intercourse or use a dual barrier method of contraception for the duration of study participation, beginning with the Screening Period, and for 3 weeks after the study ends
• Participation in another clinical trial less than 3 months before screening or concurrently with this study
• Taking more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine, or 40 ml of spirits) in the week in the last month before inclusion in the study or anamnestic evidence of alcoholism, drug abuse, or medication abuse
• Smoking more than 10 cigarettes per day currently, or a history of smoking this number of cigarettes in the 6 months prior to screening
• A positive blood test for HIV, syphilis, hepatitis B/C
• A positive urine test for narcotics and powerful drugs
• Positive breath alcohol test
• Positive COVID-19 test
• Scheduled inpatient hospitalization during the study for any reason other than hospitalization as required by this protocol
• Inability or inability to meet the requirements of the protocol, including for physical, mental or social reasons, in the opinion of the Researcher
• Work/study regimen that is likely to make it impossible for the volunteer to complete the study and/or comply with the schedule of procedures
• Other conditions that, in the opinion of the Researcher, prevent the inclusion of the volunteer in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Valenta Pharm JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Limited Liability Company "X7 Clinical Research"

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

DIO-01-04-2021

Identifier Type: -

Identifier Source: org_study_id