RecruitingPhase 1NCT07645534

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.


Sponsor

Valenta Pharm JSC

Enrollment

36 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ingavirin forte, capsules, 90 mg + 20 mg and a drug called Ingavirin, capsules, 90 mg for people with acute respiratory viral infections and influenza. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIngavirin 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)

DRUGIngavirin, capsules, 90 mg

Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid


Locations(1)

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

Saint Petersburg, Russia

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NCT07645534


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