- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558462
Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers
October 9, 2023 updated by: Valenta Pharm JSC
A Randomized, Open-label, Cross-over Study in Two Periods and Two Sequences to Evaluate the Comparative Pharmacokinetics and Bioavailability of XC8, 10 mg Film-coated Tablets, and XC8, 40 mg Film-coated Tablets, When Taken Once in Equal Doses (40 mg) on an Empty Stomach in Healthy Volunteers
Comparative study of the pharmacokinetics of XC8, film-coated tablets, 10 mg and XC8, film-coated tablets, 40 mg, when administered once in equal doses (40 mg) on an empty stomach in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Moscow, Russian Federation, 119991
- I.M. Sechenov First Moscow State Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Men and women between the ages of 18 and 45 years (inclusive) of Caucasian race;
- Verified diagnosis "healthy" (absence of abnormalities according to clinical, laboratory, instrumental methods of examination, stipulated by the protocol);
- Blood pressure (BP): systolic blood pressure (SBP) of 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) of 70 to 89 mmHg (inclusive);
- Heart rate (HR) from 60 to 89 beats/min (inclusive);
- Respiratory rate (HR) from 12 to 20 per minute (inclusive);
- Body temperature from 36°C to 36.9°C (inclusive);
- Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with a body weight of ≥ 55 kg for men and ≥ 45 kg for women;
- Consent to use adequate methods of contraception throughout the study and for 30 days after completion; for women of preserved reproductive potential, a negative urine pregnancy test result.
Exclusion Criteria:
- A history of allergy;
- Drug intolerance to the active substance XC8 (N-[2-(1H-imidazol-4-yl)-ethyl]-6-oxo-δ-lactam) and/or excipients contained in the studied drug in the anamnesis;
- Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, blood and vision;
- History of gastrointestinal surgery (except appendectomy at least 1 year prior to screening);
- Diseases/conditions that, in the opinion of the investigator, may affect absorption, distribution, metabolism or excretion of the investigational drugs;
- Acute infectious disease 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 prior to screening;
- Regularly taking an medicine less than 2 weeks before screening and taking a single medicine less than 7 days before screening;
- Donating blood or plasma less than 3 months before screening;
- Use of hormonal contraceptives (in women) less than 2 months before screening;
- The use of depot injections of any drug less than 3 months before screening;
- Pregnancy or lactation; positive urine pregnancy test for women of preserved reproductive potential;
- Women of preserved reproductive potential with a history of unprotected intercourse within 30 days prior to study drug administration with an unsterilized partner;
- Participation in another clinical trial less than 3 months prior to screening or concurrently with the present 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 addiction, drug abuse;
- Smoking more than 10 cigarettes per day currently, or a history of smoking the specified number of cigarettes during the 6 months prior to screening; disagreement to abstain from smoking for the duration of the hospital stay;
- Consumption of alcohol, caffeine, and xanthine-containing products 7 days prior to the study drug admission;
- Consumption of citrus fruits, cranberries and products containing them, preparations or products containing St. John's wort - 7 days before admission to the study drug;
- Dehydration due to diarrhea, vomiting, or other reason within the last 24 hours prior to study drug administration.
- Positive blood tests for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at screening;
- Rapid tests of biomaterial (nasopharyngeal and/or oropharyngeal swab) for Severe Acute Respiratory Syndrome Coronavirus 2 antigen (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19) at screening;
- Clinically significant abnormalities on an electrocardiogram (ECG) history and/or at screening;
- Positive urinalysis for narcotics and powerful drugs at screening;
- Positive breath alcohol vapor test at screening.
- Scheduling an inpatient stay at the time of the study, for any reason other than hospitalization required by this protocol;
- Inability or inability to meet the requirements of the protocol, perform the procedures prescribed by the protocol, follow the diet, activity regimen.
- Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical and dental schools, junior staff of clinics and laboratories, employees of pharmaceutical companies, servicemen and prisoners, persons in nursing homes, low-income and unemployed, national minorities, homeless people, vagrants, refugees, persons under guardianship or custody, and persons unable to give consent, and law enforcement officers;
- Other conditions that, in the opinion of the Researcher, prevent the inclusion of the volunteer in the study or that might lead to early withdrawal of the volunteer from the study, including fasting or a special diet (e.g. vegetarian, vegan, restricted salt intake) or a special lifestyle (night work, extreme physical activity).
Withdrawal Criteria:
- The volunteer's refusal to further participate in the study;
- Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
- Volunteers selected for the study in violation of the inclusion/inclusion criteria;
- Development of severe adverse event in the volunteer during the study;
- The volunteer is undergoing or requires treatment that may affect the pharmacokinetic parameters;
- Missing 2 or more consecutive blood samples or 3 or more blood samples during the same Study Period;
- Occurrence of vomiting/diarrhea within 4 hours of study drug administration;
- Positive urine test for narcotics and powerful drugs;
- Positive breath alcohol vapor test.
- Positive pregnancy test in women;
- Positive test for COVID-19;
- The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RT-sequence
Group 1 (12 volunteers, RT sequence) will take 4 tablets of XC8, 10 mg, in Period 1 and 1 tablet of XC8, 40 mg, in Period 2
|
A single dose of R or T drug in each of 2 periods of the study in fasted conditions
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Experimental: TR-sequence
Group 2 (12 volunteers, sequence TR) will take 1 tablet of XC8, 40 mg, in Period 1 and 4 tablets of XC8, 10 mg, in Period 2.
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A single dose of R or T drug in each of 2 periods of the study in fasted conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics - Cmax
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
|
Maximum plasma concentration (Cmax)
|
From 0 to 24 hours (Day 1-2 and Day 8-9)
|
Pharmacokinetics - tmax
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
|
Time to reach Cmax (tmax)
|
From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - AUC0-t
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
|
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
|
From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - AUC0-inf
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - AUCextr
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Extrapolated AUC, defined as (AUC0-inf - AUC0-t)/AUC0-inf
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - t1/2
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Elimination half-life (t1/2)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - kel
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Elimination constant (kel)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Pharmacokinetics - MRT
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Mean residence time (MRT)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Bioequivalence - ratio of Cmax
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Bioequivalence - ratio of AUC0-t
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Bioequivalence - ratio of AUC0-inf
Time Frame: From 0 to 24 hours (Day 1-2 and Day 8-9)
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Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals)
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From 0 to 24 hours (Day 1-2 and Day 8-9)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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SBP, mmHg
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Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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DBP, mmHg
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Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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Safety and Tolerability: vital signs - respiratory rate (RR)
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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RR, breaths per minute
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Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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Safety and Tolerability: vital signs - heart rate (HR)
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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HR, beats per minute
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Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
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Safety and Tolerability: vital signs - body temperature
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Body temperature, centigrade scale
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Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: adverse event (AE) number and frequency
Time Frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Number and frequency of adverse events (AEs)
|
From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
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Safety and Tolerability: serious adverse event (SAE) number and frequency
Time Frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Number and frequency of serious AEs (SAEs)
|
From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: physical examination results
Time Frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
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.
The findings (if any) will be reported as the rate of clinically significant findings by each system level assessed.
|
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - color
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Color of the urine
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - transparency
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Transparency of the urine
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - pH
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
pH of the urine
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - specific gravity
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Specific gravity of the urine
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - protein
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Protein in the urine (g/L)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis - glucose
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Glucose in the urine (mmol/L)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Red blood cells in the urine (number in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - white blood cells
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
White blood cells in the urine (number in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - epithelial cells
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Epithelial cells in the urine (number in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - cylinders
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Cylinders in the urine (number in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - mucus
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Mucus in the urine (presence in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: urinalysis (microscopy) - bacteria
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Bacteria in the urine (number in sight)
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - hemoglobin
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Hemoglobin, g/dL
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - red blood cells
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Red blood cells, 10^6/uL
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - hematocrit
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Hematocrit, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - platelets
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Platelets, 10^3/uL
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - white blood cells
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
White blood cells, 10^3/uL
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Erythrocyte sedimentation rate, mm per hour
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - neutrophils
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Neutrophils, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - lymphocytes
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Lymphocytes, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - eosinophils
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Eosinophils, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - monocytes
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Monocytes, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: complete blood count - basophils
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Basophils, %
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - total protein
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Total protein in blood serum, g/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - creatinine
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Creatinine in blood serum, umol/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - glucose
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Glucose in blood serum, mmol/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - total bilirubin
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Total bilirubin in blood serum, umol/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - total cholesterol
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Total cholesterol in blood serum, mmol/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - alanine transaminase (ALT)
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
ALT in blood serum, U/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - aspartate transaminase (AST)
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
AST in blood serum, U/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
Time Frame: Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
ALP in blood serum, U/L
|
Screening, Day 2, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2022
Primary Completion (Actual)
November 11, 2022
Study Completion (Actual)
December 7, 2022
Study Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
September 27, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 9, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XC8-05-04-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
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NPO PetrovaxCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza EpidemicRussian Federation
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National Institute of Allergy and Infectious Diseases...Completed
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National Institute of Allergy and Infectious Diseases...Completed
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National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
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National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
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National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
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National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
Clinical Trials on XC8
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Valenta Pharm JSCCompletedHealthyRussian Federation
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Valenta Pharm JSCRecruitingEfficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral InfectionsAcute Respiratory InfectionRussian Federation
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Valenta Pharm JSCCompletedInfluenza, Human | Common Cold | Acute Respiratory InfectionRussian Federation
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Valenta Pharm JSCCompletedInfluenza, Human | Common Cold | Acute Respiratory InfectionRussian Federation
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PHARMENTERPRISES LLCCompletedInfluenza | Acute Respiratory InfectionRussian Federation
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EURRUS Biotech GmbHCompleted
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Chemlmmune Therapeutics LLCEURRUS Biotech GmbHCompletedEosinophilic Asthma | Bronchial AsthmaRussian Federation
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PHARMENTERPRISES LLCCompleted
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PHARMENTERPRISES LLCEURRUS Biotech GmbHCompleted