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The study aimed for:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCD-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence A-B-C-D during the corresponding study periods 1, 2, 3, and 4 |
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| BCDA-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence B-C-D-A during the corresponding study periods 1, 2, 3, and 4 |
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| CDAB-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence C-D-A-B during the corresponding study periods 1, 2, 3, and 4 |
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| DABC-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence D-A-B-C during the corresponding study periods 1, 2, 3, and 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Safety and Tolerability: serious adverse event (AE) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limited Liability Company "X7 Clinical Research" | Saint Petersburg | 194156 | Russia |
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| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D007239 | Infections |
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