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.

NCT07645534 | Recruiting Phase 1

• 1 other identifier: IFR-01-02-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; Acute Respiratory Viral Infections

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (59)

• Adverse event type

  From Screening to Day 29 ± 1

• Adverse event number

  From Screening to Day 29 ± 1

• Adverse event severety

  From Screening to Day 29 ± 1

• Discontinuations due to adverse events related to the investigational product

  From Screening to Day 29 ± 1

• Safety and Tolerability: volunteer complaints

  From Screening to Day 29 ± 1

Study Arms (4)

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.

Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg

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.

Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg

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.

Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg

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.

Drug: Ingavirin forte, capsules, 90 mg + 20 mg; Drug: Ingavirin, capsules, 90 mg

Interventions

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)

Also known as: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9)

ACBD sequence; BADC sequence; CDAB sequence; DBCA sequence

Ingavirin, capsules, 90 mg DRUG

Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid

Also known as: imidazolylethanamide of pentanedioic acid

ACBD sequence; BADC sequence; CDAB sequence; DBCA sequence

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
• Males and females aged 18 to 45 years (inclusive);
• 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;
• Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);
• Heart rate (HR) from 60 to 89 beats/min (inclusive);
• Respiratory rate (RR) from 12 to 20 per minute (inclusive);
• Body temperature from 36.0°C to 36.9°C (inclusive);
• 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;
• 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;
• Subjects must demonstrate appropriate behavior and coherent speech;
• Ability to comply with the daily routine and diet prescribed by the study protocol.
• Clinically significant allergic history;
• 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;
• 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;
• Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;

You may not qualify if:

• Subject's decision to discontinue participation in the study;
• 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.
• Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);
• Prolongation of the QTcF interval on ECG recording (\>500 ms or \>60 ms compared to baseline measured on Days 1, 8, 15, and 22);
• Occurrence of a severe adverse event (AE) and/or serious adverse event (SAE) during study participation
• Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;
• The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
• Occurrence of vomiting/diarrhea within 8 hours after administration of the study drug;
• Positive urine test for narcotic substances and potent medicinal products;
• Positive breath alcohol test;
• Positive urine β-hCG test result in women;
• Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (1)

Federal Budgetary Institution of Science "North-West Public Health Research Center"

Saint Petersburg, 191036, Russia

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Capsules; pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 12, 2026
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

RU (1)