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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05505097
Other study ID # DIO-01-04-2021
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 4, 2022
Est. completion date December 19, 2022

Study information

Verified date August 2023
Source Valenta Pharm JSC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 19, 2022
Est. primary completion date December 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation Limited Liability Company "X7 Clinical Research" Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Valenta Pharm JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Safety and Tolerability: adverse event (AE) rate Number and frequency of adverse events (AEs) or serious AEs (SAEs) 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
Secondary Safety and Tolerability: serious adverse event (AE) rate Number and frequency of serious AEs (SAEs) 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
Secondary Safety and Tolerability: vital signs - systolic blood pressure (SBP) SBP, mmHg 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
Secondary Safety and Tolerability: vital signs - diastolic blood pressure (DBP) DBP, mmHg 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
Secondary Safety and Tolerability: vital signs - respiratory rate (RR) RR, breaths per minute 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
Secondary Safety and Tolerability: vital signs - heart rate (HR) HR, beats per minute 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
Secondary Safety and Tolerability: vital signs - body temperature Body temperature, centigrade scale 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
Secondary Safety and Tolerability: physical examination results Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially. Screening, -10 h, -1 h, 2 h, 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
Secondary Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute) Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Secondary Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms) Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Secondary Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms) Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Secondary Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc) 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms) Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Secondary Safety and Tolerability: complete blood count - hemoglobin Hemoglobin, g/dL Screening, 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
Secondary Safety and Tolerability: complete blood count - red blood cells Red blood cells, 10^6/uL Screening, 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
Secondary Safety and Tolerability: complete blood count - hematocrit Hematocrit, % Screening, 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
Secondary Safety and Tolerability: complete blood count - platelets Platelets, 10^3/uL Screening, 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
Secondary Safety and Tolerability: complete blood count - white blood cells White blood cells, 10^3/uL Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Secondary Safety and Tolerability: complete blood count - erythrocyte sedimentation rate Erythrocyte sedimentation rate, mm per hour Screening, 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
Secondary Safety and Tolerability: complete blood count - lymphocytes Lymphocytes, % Screening, 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
Secondary Safety and Tolerability: complete blood count - eosinophils Eosinophils, % Screening, 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
Secondary Safety and Tolerability: complete blood count - monocytes Monocytes, % Screening, 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
Secondary Safety and Tolerability: complete blood count - basophils Basophils, % Screening, 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
Secondary Safety and Tolerability: complete blood count - neutrophils Neutrophils, % (segmented and stab) Screening, 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
Secondary Safety and Tolerability: blood test results - glucose Glucose in blood serum, mmol/L Screening, 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
Secondary Safety and Tolerability: blood test results - total cholesterol Total cholesterol in blood serum, mmol/L Screening, 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
Secondary Safety and Tolerability: blood test results - total protein Total protein in blood serum, g/L Screening, 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
Secondary Safety and Tolerability: blood test results - total bilirubin Total bilirubin in blood serum, umol/L Screening, 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
Secondary Safety and Tolerability: blood test results - creatinine Creatinine in blood serum, umol/L Screening, 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
Secondary Safety and Tolerability: blood test results - alkaline phosphatase (ALP) ALP in blood serum, U/L Screening, 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
Secondary Safety and Tolerability: blood test results - alanine transaminase (ALT) ALT in blood serum, U/L Screening, 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
Secondary Safety and Tolerability: blood test results - aspartate transaminase (AST) AST in blood serum, U/L Screening, 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
Secondary Safety and Tolerability: blood test results - aldosterone Aldosterone in blood serum, pmol/L Screening, 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
Secondary Safety and Tolerability: blood test results - cortisol Cortisol in blood serum, pmol/L Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Secondary Safety and Tolerability: urinalysis - specific gravity Specific gravity of the urine Screening, 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
Secondary Safety and Tolerability: urinalysis - color Color of the urine Screening, 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
Secondary Safety and Tolerability: urinalysis - transparency Transparency of the urine Screening, 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
Secondary Safety and Tolerability: urinalysis - pH pH of the urine Screening, 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
Secondary Safety and Tolerability: urinalysis - protein Protein in the urine (g/L) Screening, 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
Secondary Safety and Tolerability: urinalysis - glucose Glucose in the urine (mmol/L) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - red blood cells Red blood cells in the urine (number in sight) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - white blood cells White blood cells in the urine (number in sight) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - epithelial cells Epithelial cells in the urine (number in sight) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - cylinders Cylinders in the urine (number in sight) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - bacteria Bacteria in the urine (number in sight) Screening, 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
Secondary Safety and Tolerability: urinalysis (microscopy) - mucus Presence of mucus in the urine Screening, 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
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