Clinical 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
Official title: Open Randomized Comparative Crossover Study of the 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Pharmacokinetics - Cmax
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - tmax
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - tlag
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - Vd
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - AUC0-t
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - AUC0-inf
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - AUCextr
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - kel
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - t1/2
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
measure: Pharmacokinetics - MRT
timeFrame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Secondary outcomes:
measure: Safety and Tolerability: adverse event (AE) rate
timeFrame: 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
measure: Safety and Tolerability: serious adverse event (AE) rate
timeFrame: 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
measure: Safety and Tolerability: vital signs - systolic blood pressure (SBP)
timeFrame: 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
measure: Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
timeFrame: 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
measure: Safety and Tolerability: vital signs - respiratory rate (RR)
timeFrame: 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
measure: Safety and Tolerability: vital signs - heart rate (HR)
timeFrame: 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
measure: Safety and Tolerability: vital signs - body temperature
timeFrame: 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
measure: Safety and Tolerability: physical examination results
timeFrame: 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
measure: Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
timeFrame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
measure: Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
timeFrame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
measure: Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
timeFrame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
measure: Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
timeFrame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
measure: Safety and Tolerability: complete blood count - hemoglobin
timeFrame: 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
measure: Safety and Tolerability: complete blood count - red blood cells
timeFrame: 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
measure: Safety and Tolerability: complete blood count - hematocrit
timeFrame: 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
measure: Safety and Tolerability: complete blood count - platelets
timeFrame: 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
measure: Safety and Tolerability: complete blood count - white blood cells
timeFrame: 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
measure: Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
timeFrame: 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
measure: Safety and Tolerability: complete blood count - lymphocytes
timeFrame: 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
measure: Safety and Tolerability: complete blood count - eosinophils
timeFrame: 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
measure: Safety and Tolerability: complete blood count - monocytes
timeFrame: 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
measure: Safety and Tolerability: complete blood count - basophils
timeFrame: 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
measure: Safety and Tolerability: complete blood count - neutrophils
timeFrame: 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
measure: Safety and Tolerability: blood test results - glucose
timeFrame: 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
measure: Safety and Tolerability: blood test results - total cholesterol
timeFrame: 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
measure: Safety and Tolerability: blood test results - total protein
timeFrame: 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
measure: Safety and Tolerability: blood test results - total bilirubin
timeFrame: 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
measure: Safety and Tolerability: blood test results - creatinine
timeFrame: 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
measure: Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
timeFrame: 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
measure: Safety and Tolerability: blood test results - alanine transaminase (ALT)
timeFrame: 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
measure: Safety and Tolerability: blood test results - aspartate transaminase (AST)
timeFrame: 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
measure: Safety and Tolerability: blood test results - aldosterone
timeFrame: 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
measure: Safety and Tolerability: blood test results - cortisol
timeFrame: 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
measure: Safety and Tolerability: urinalysis - specific gravity
timeFrame: 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
measure: Safety and Tolerability: urinalysis - color
timeFrame: 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
measure: Safety and Tolerability: urinalysis - transparency
timeFrame: 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
measure: Safety and Tolerability: urinalysis - pH
timeFrame: 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
measure: Safety and Tolerability: urinalysis - protein
timeFrame: 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
measure: Safety and Tolerability: urinalysis - glucose
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - red blood cells
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - white blood cells
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - epithelial cells
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - cylinders
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - bacteria
timeFrame: 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
measure: Safety and Tolerability: urinalysis (microscopy) - mucus
timeFrame: 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
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "X7 Clinical Research"
Study officials:
References: