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An Open-label Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte Capsules Following Single and Multiple Oral Administration in Healthy Volunteers
Led by Valenta Pharm JSC · Updated on 2025-07-08
36
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, single-center study to assess the safety, tolerability, and how the body processes different ascending doses of Ingavirin Forte capsules in healthy adult volunteers. This study focuses on understanding the effects of the drug in people without influenza or viral respiratory infection symptoms, aiming to gather important information about the drug's profile when given as single and multiple oral doses. Participants will receive Ingavirin Forte capsules in increasing doses: 90 mg combined with either 5 mg, 10 mg, or 20 mg of an additional compound. Each participant takes one capsule under fasting conditions, followed by twice-daily dosing for two days (first dose fasting, second dose two hours after a meal), and a final morning dose under fasting on the third day. A wash-out period of 7 to 21 days follows the single-dose phase before the next stage. During the study, participants will be closely monitored through physical exams, vital signs checks, blood and urine tests, and electrocardiograms. The study will measure how the drug is absorbed, reaches peak levels, and is eliminated over time. Safety is evaluated by recording any adverse events, physical complaints, and lab test results throughout screening, dosing, wash-out, and observation periods. The total participation duration varies with each dosing phase and monitoring schedule.
CONDITIONS
Brief Title
Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any study activities.
- Male and female participants aged 18 to 45 years inclusive of Caucasian race.
- Verified healthy status with no abnormalities by clinical, laboratory, and instrumental exams.
- Blood pressure: systolic 100 to 130 mm Hg and diastolic 70 to 85 mm Hg.
- Heart rate between 60 to 89 beats per minute.
- Respiratory rate between 12 to 20 breaths per minute.
- Body temperature from 36.0�B0C to 36.9�B0C.
- Body mass index between 18.5 and 30 kg/m�B2, with minimum weight �B5 55 kg for men and �B5 45 kg for women.
- Agreement to use adequate contraception during the study and for 30 days after; negative urine pregnancy test for women of childbearing potential.
You will not qualify if you...
- History of allergic reactions or hypersensitivity to the study drug or its ingredients.
- Intolerance to the study drug or excipients.
- Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
- Chronic diseases of kidneys, liver, gastrointestinal, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or vision organs.
- History of gastrointestinal surgery except appendectomy over 1 year ago.
- Conditions affecting drug absorption, distribution, metabolism, or excretion.
- Acute infectious diseases within 4 weeks before screening.
- Use of drugs affecting hemodynamics, liver function, or prolonging QT interval within 2 months before screening.
- Regular drug use less than 2 weeks and single use less than 7 days before screening.
- Blood or plasma donation within 3 months before screening.
- Use of hormonal contraceptives within 2 months before screening.
- Use of depot injections less than 3 months before screening.
- Pregnancy or lactation; positive pregnancy test.
- Unprotected sexual intercourse within 30 days prior to medication for women of childbearing potential.
- Participation in another clinical trial within 3 months or concurrent.
- Excessive alcohol consumption or substance abuse history.
- Smoking more than 10 cigarettes per day currently or in past 6 months; unwillingness to refrain during the study.
- Consumption of alcohol, caffeine, xanthine products, citrus fruits, cranberries, rose hips, St. John's wort within 7 days prior to dosing.
- Dehydration within 24 hours before dosing.
- Positive tests for HIV, hepatitis B or C, syphilis, narcotics, or alcohol vapors at screening.
- Significant ECG abnormalities or risk factors for torsades de pointes.
- Planned hospitalization during study except as per protocol.
- Inability or unwillingness to comply with protocol or lifestyle requirements.
- Belonging to vulnerable volunteer groups.
- Other investigator-judged conditions affecting participation or causing early withdrawal.
- Withdrawal from study or non-compliance during study.
- Severe adverse events or reactions during study.
- Vomiting or diarrhea within 8 hours after dosing.
- Missing multiple blood samples during study.
- Positive pregnancy test during study.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants take ascending doses of Ingavirin Forte capsules, starting with a single dose under fasted conditions, followed by multiple doses twice a day for 2 days and a final dose on the third day under fasted conditions.
Daily visits for 3 days during dosing
Duration - 7 to 21 days
Participants undergo a wash-out period following the single-dose treatment to monitor safety and pharmacokinetics.
Visits as needed during wash-out period
Duration - Up to 11 days after multiple dosing
Participants are observed for safety and pharmacokinetics after multiple dosing of Ingavirin Forte.
Visits for assessments up to Day 11
Trial Site Locations
Total: 1 location
1
State Budgetary Healthcare Institution of the City of Moscow "City Clinical Hospital No. 15 named after O.M. Filatov of the Department of Health of Moscow."
Moscow, Russia
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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