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.

Sponsor
Valenta Pharm JSC
Study ID
NCT07645534
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Respiratory Viral Infections
  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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)
  • Ingavirin, capsules, 90 mg — DRUG
    Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid

Study Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Jul 11, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Pharmacokinetics - Cmax [ Time Frame: From 0 to 24 hours ]

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