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This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACBD sequence | Experimental | ACBD sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. |
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| BADC sequence | Experimental | BADC sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. |
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| CDAB sequence | Experimental | CDAB sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. |
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| DBCA sequence | Experimental | DBCA sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin forte, capsules, 90 mg + 20 mg | Drug | Ingavirin forte containing 90 mg of imidazolylethanamide of pentanedioic acid and 20 mg of N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax | Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below. | From 0 to 24 hours |
| Pharmacokinetics - tmax | Time to reach Cmax (tmax) | From 0 to 24 hours |
| Pharmacokinetics - AUC0-t | Area under the plasma concentration-time curve from time 0 to t (AUC0-t) | From 0 to 24 hours |
| Pharmacokinetics - AUC0-inf | Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) | From 0 to 24 hours |
| Pharmacokinetics - AUCextr | Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf | From 0 to 24 hours |
| Pharmacokinetics - t1/2 | Elimination half-life (t1/2) | From 0 to 24 hours |
| Pharmacokinetics - kel | Elimination constant (kel) | From 0 to 24 hours |
| Pharmacokinetics - number of terminal timepoints | Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event type | Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA. | From Screening to Day 29 ± 1 |
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Inclusion Criteria:
Noninclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Budgetary Institution of Science "North-West Public Health Research Center" | Recruiting | Saint Petersburg | 191036 | Russia |
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| Ingavirin, capsules, 90 mg | Drug | Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid |
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| From 0 to 24 hours |
| Adverse event number | Number of adverse events registered during the study | From Screening to Day 29 ± 1 |
| Adverse event severety | Severity of adverse events registered during the study, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) | From Screening to Day 29 ± 1 |
| Discontinuations due to adverse events related to the investigational product | Number of subjects who discontinued the study early due to adverse events (including serious adverse events) related to the investigational product | From Screening to Day 29 ± 1 |
| Safety and Tolerability: volunteer complaints | Description of any health-related complaints received from volunteer | From Screening to Day 29 ± 1 |
| Safety and Tolerability: physical examination results - cardiovascular system | An assessment of the condition of the cardiovascular system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/cardiovascular symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - respiratory system | An assessment of the condition of the respiratory system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/respiratory symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - digestive tract | An assessment of the condition of the digestive tract and associated symptoms on physical examination (normal condition or a description of abnormal conditions/digestive tract symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - endocrine system | An assessment of the condition of the endocrine system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/endocrine symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - musculoskeletal system | An assessment of the condition of the musculoskeletal system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/musculoskeletal symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - nervous system | An assessment of the condition of the nervous system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/neurological symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - sensory systems | An assessment of the condition of the sensory systems and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: physical examination results - skin/visible mucous membranes | An assessment of the condition of the skin/visible mucous membranes and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any) | From Screening to Day 23 |
| Safety and Tolerability: vital signs - systolic blood pressure | Systolic blood pressure (SBP, mmHg) | From Screening to Day 23 |
| Safety and Tolerability: vital signs - diastolic blood pressure | Diastolic blood pressure (DBP, mmHg) | From Screening to Day 23 |
| Safety and Tolerability: vital signs - heart rate | Heart rate (HR, bpm) | From Screening to Day 23 |
| Safety and Tolerability: vital signs - body temperature (Celsius temperature scale) | Body temperature (Celsius temperature scale) | From Screening to Day 23 |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate | 12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute) | From Screening to Day 23 |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval | 12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex) | From Screening to Day 23 |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex | 12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram) | From Screening to Day 23 |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval | 12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave; Fredericia correction) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - hemoglobin | Hemoglobin (g/L) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - hematocrit | Hematocrit (%) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - red blood cell count | Red blood cell count (cells/L) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - platelet count | Platelet count (cells/L) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - leukocyte count | Leukocyte count (cells/L) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate | Erythrocyte sedimentation rate (mm/h) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - myelocytes | Leukocyte formula (myelocytes, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - band neutrophils | Leukocyte formula (band neutrophils, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - segmented neutrophils | Leukocyte formula (segmented neutrophils, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - eosinophils | Leukocyte formula (eosinophils, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - basophils | Leukocyte formula (basophils, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - monocytes | Leukocyte formula (monocytes, %) | From Screening to Day 23 |
| Safety and Tolerability: clinical blood test - lymphocytes | Leukocyte formula (lymphocytes, %) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - specific gravity | Specific gravity of the urine | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - color | Color of the urine | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - transparency | Transparency of the urine | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - pH | pH of the urine | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - protein | Protein concentration (g/L) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - glucose | Glucose concentration (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - red blood cells | Red blood cell content (number in sight) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - white blood cells | White blood cell content (number in sight) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - epithelial cells | Epithelial cell content (number in sight) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - casts | Presence of casts (Yes/No) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - mucus | Presence of mucus (Yes/No) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis - bacteria | Presence of bacteria (Yes/No) | From Screening to Day 23 |
| Safety and Tolerability: urinalysis (microscopy) | Changes in urine sediment parameters (RBCs, WBCs, casts, crystals) as assessed by microscopy | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - glucose | Glucose concentration (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - cholesterol | Total cholesterol concentration (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - protein | Total protein concentration (g/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - bilirubin | Total bilirubin concentration (micromol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - creatinine | Creatinine concentration (micromol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - alkaline phosphatase | Alkaline phosphatase activity (U/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - alanine transaminase | Alanine transaminase activity (U/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - aspartate transaminase | Aspartate transaminase activity (U/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - potassium concentration | Potassium (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - sodium concentration | Sodium concentration (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - chloride concentration | Chloride concentration (mmol/L) | From Screening to Day 23 |
| Safety and Tolerability: blood chemistry - GFR | Glomerular filtration rate, GFR (mL/min/1,73 м²) | From Screening to Day 23 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| C539419 | pentanedioic acid imidazolyl ethanamide |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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