Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.

An Open-Label, Randomized, Crossover Clinical Study to Evaluate the Safety and Pharmacokinetics of the Active Ingredients of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Fixed-Dose Combination Compared With Single-Ingredient Drug Ingavirin, Capsules, 90 mg Under Fasting and Fed Conditions.

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza; Acute Respiratory Viral Infections
• Intervention / Treatment: Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russia
  • Saint Petersburg, Russia, 191036
    • Recruiting
    • Federal Budgetary Institution of Science "North-West Public Health Research Center"
    • Contact: Elena Shalukho, MD; Phone Number: +7 (903) 099 57 86; Email: Elena.Shalukho@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
2. Males and females aged 18 to 45 years (inclusive);
3. Confirmed healthy status, defined as the absence of clinically significant abnormalities based on clinical evaluation, laboratory assessments, and diagnostic procedures as specified in the protocol;
4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);
5. Heart rate (HR) from 60 to 89 beats/min (inclusive);
6. Respiratory rate (RR) from 12 to 20 per minute (inclusive);
7. Body temperature from 36.0°C to 36.9°C (inclusive);
8. Body mass index (BMI) of 18.5 kg/m² ≤ BMI ≤ 30 kg/m², with body weight for men being ≥ 55 kg and for women ≥ 45 kg;
9. Agreement to use adequate methods of contraception throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine β-hCG test result;
10. Subjects must demonstrate appropriate behavior and coherent speech;
11. Ability to comply with the daily routine and diet prescribed by the study protocol.

Noninclusion Criteria:

1. Clinically significant allergic history;
2. History of hypersensitivity to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
3. History of drug intolerance to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
5. Chronic diseases of the kidneys, liver, gastrointestinal (GI) tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary, or immune systems, or of the skin, hematopoietic organs, or eyes;
6. History of gastrointestinal (GI) surgical procedures, with the exception of appendectomy performed at least 1 year prior to screening;
7. Diseases/conditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the investigational medicinal product (IMP);
8. Acute infectious diseases less than 4 weeks prior to screening;
9. Use of medicinal products (MPs) that have a pronounced effect on hemodynamics, MPs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), MPs prolonging the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)) less than 2 months prior to screening;
10. Regular use of MPs less than 2 weeks prior to screening and single use of MPs less than 7 days prior to screening (including over-the-counter MPs, vitamins, dietary supplements, herbal medicinal products);
11. Donation of blood or plasma less than 3 months prior to screening;
12. Use of hormonal contraceptives by womeninitiated less than 2 months prior to the screening visit.
13. Use of depot injections of any MPs less than 3 months prior to the start of screening;
14. Pregnancy or breastfeeding; positive urine pregnancy test result for women of childbearing potential;
15. Women of childbearing potential with a history of unprotected sexual intercourse within 30 days prior to study drug administration with a non-sterilized partner;
16. Participation in another clinical trial within 3 months prior to screening or concurrently with the current study.
17. Consumption of more than 10 standard alcohol units per week during the month prior to study enrollment, (1 standard unit = 500 mL beer, 200 mL wine, or 50 mL of strong alcoholic beverages), or history of alcoholism, drug dependence, or substance abuse.
18. Currently smoking more than 10 cigarettes per day, or a history of smoking the specified number of cigarettes within the 6 months preceding screening; refusal to abstain from smoking while staying at the study center;
19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to IMP administration;
20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or St. John's wort-containing preparations or products within 7 days prior to IMP administration;
21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to IMP administration;
22. Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus antigens at screening;
23. Clinically significant abnormalities on the electrocardiogram (ECG) in the medical history and/or at screening, including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women;
24. History of risk factors for torsades de pointes, such as heart failure, hypokalemia, or family history of long QT syndrome;
25. Electrolyte imbalances (based on Na+, K+, Cl- levels at screening);
26. Positive urine test for narcotic substances and potent medicinal products at screening;
27. Positive breath alcohol test at screening;
28. Planned hospitalization during the study period for any reason other than hospitalization required by this protocol;
29. Inability or incapacity to comply with the protocol requirements, perform protocol-specified procedures, or adhere to the diet and activity restrictions;
30. Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical, and dental educational institutions; subordinate clinical or laboratory staff; employees of pharmaceutical companies; military personnel and prisoners; residents of long-term care facilities; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or trusteeship; persons incapable of providing informed consent; as well as law enforcement officers;
31. Any other condition which, in the Investigator's judgment, would preclude the subject's enrollment in the study or could lead to premature withdrawal, including adherence to fasting practices or special diets (e.g., vegetarian, vegan, sodium-restricted) or lifestyle factors (e.g., night shift work, extreme physical exertion).

Exclusion criteria:

1. Subject's decision to discontinue participation in the study;
2. Subject non-compliance with protocol requirements, including but not limited to missed study procedures, unauthorized use of prohibited concomitant medications, or failure to adhere to protocol-defined dietary and lifestyle restrictions.
3. Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);
4. Subjects enrolled in the study despite not meeting eligibility criteria (inclusion/exclusion criteria violations).
5. Prolongation of the QTcF interval on ECG recording (>500 ms or >60 ms compared to baseline measured on Days 1, 8, 15, and 22);
6. Occurrence of a severe adverse event (AE) and/or serious adverse event (SAE) during study participation
7. Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;
8. The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
9. Occurrence of vomiting/diarrhea within 8 hours after administration of the study drug;
10. Positive urine test for narcotic substances and potent medicinal products;
11. Positive breath alcohol test;
12. Positive urine β-hCG test result in women;
13. Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACBD sequence; 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.	Drug: Ingavirin forte, capsules, 90 mg + 20 mg; 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); Other Names: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9); Drug: Ingavirin, capsules, 90 mg; Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid; Other Names: imidazolylethanamide of pentanedioic acid
Experimental: BADC sequence; 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.	Drug: Ingavirin forte, capsules, 90 mg + 20 mg; 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); Other Names: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9); Drug: Ingavirin, capsules, 90 mg; Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid; Other Names: imidazolylethanamide of pentanedioic acid
Experimental: CDAB sequence; 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.	Drug: Ingavirin forte, capsules, 90 mg + 20 mg; 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); Other Names: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9); Drug: Ingavirin, capsules, 90 mg; Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid; Other Names: imidazolylethanamide of pentanedioic acid
Experimental: DBCA sequence; 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.	Drug: Ingavirin forte, capsules, 90 mg + 20 mg; 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); Other Names: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9); Drug: Ingavirin, capsules, 90 mg; Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid; Other Names: imidazolylethanamide of pentanedioic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	From 0 to 24 hours

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Pharmaceutical Preparations; Dosage Forms; Capsules; pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: IFR-01-02-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No