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 | Completed Phase 1

• 1 other identifier: DIO-01-04-2021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed for:

1. 1.To study the safety of the drug Dioxidin, solution for topical and external use;
2. 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. 3.To study pharmacokinetics of the drug Dioxidin, solution for topical and external application;
4. 4.To determine the absolute bioavailability of the drug Dioxidine, solution for topical and external use.

Conditions

Infections

Outcome Measures

Primary Outcomes (10)

• Pharmacokinetics - Cmax

  Maximum plasma concentration (Cmax) of Hydroxymethylquinoxalindioxyde (HMQD)

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - tmax

  Time to reach Cmax (tmax) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - tlag

  Time from administration to first accessible concentration of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - Vd

  Volume of distribution of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - AUC0-t

  Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - AUC0-inf

  Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - AUCextr

  Extrapolated AUC of HMQD, defined as (AUC0-inf - AUC0-t)/AUC0-inf

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - kel

  Elimination constant (kel) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - t1/2

  Elimination half-life (t1/2) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

• Pharmacokinetics - MRT

  Mean residence time (MRT) of HMQD

  From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study

Secondary Outcomes (45)

• Safety and Tolerability: adverse event (AE) rate

  From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant

• Safety and Tolerability: serious adverse event (AE) rate

  From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant

• Safety and Tolerability: vital signs - systolic blood pressure (SBP)

  Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation

• Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

  Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation

• Safety and Tolerability: vital signs - respiratory rate (RR)

  Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation

Study Arms (4)

ABCD-sequence

OTHER

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

Drug: Hydroxymethylquinoxalindioxyde

BCDA-sequence

OTHER

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

Drug: Hydroxymethylquinoxalindioxyde

CDAB-sequence

OTHER

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

Drug: Hydroxymethylquinoxalindioxyde

DABC-sequence

OTHER

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

Drug: Hydroxymethylquinoxalindioxyde

Interventions

Hydroxymethylquinoxalindioxyde 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

Also known as: Dioxidin

ABCD-sequence; BCDA-sequence; CDAB-sequence; DABC-sequence

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (1)

Limited Liability Company "X7 Clinical Research"

Saint Petersburg, 194156, Russia

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 17, 2022
• Study Start: May 4, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

RU (1)