Actively Recruiting
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers
Led by Valenta Pharm JSC · Updated on 2025-07-10
24
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin, a metered dose topical spray, compared to Grammidin lozenges following single administration in healthy volunteers .
CONDITIONS
Official Title
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form prior to any study-related procedures
- Male or female aged 18 to 45 years inclusive
- Verified healthy status with no clinically significant abnormalities
- Blood pressure: systolic 99-129 mm Hg, diastolic 70-89 mm Hg
- Heart rate between 60 and 89 beats per minute
- Respiratory rate between 12 and 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; minimum weight �b1 55 kg for men and �b1 45 kg for women
- Consent to use effective contraceptive methods during the study and for 30 days after completion; negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of clinically significant allergies or hypersensitivity to study drugs
- Drug intolerance to active or excipient substances in study drugs
- Chronic diseases affecting kidneys, liver, gastrointestinal, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or eyes
- Oral mucosa lesions such as aphthous stomatitis or herpes
- Prior gastrointestinal surgery except appendectomy more than 1 year ago
- Conditions affecting drug absorption, distribution, metabolism, or excretion
- Acute infections within 4 weeks before screening
- Use of medications affecting hemodynamics or liver function within 2 months before screening
- Regular medication use within 2 weeks or single use within 7 days before screening
- Blood or plasma donation within 3 months before screening
- Use of hormonal contraceptives within 2 months before screening
- Depot medication injections within 3 months before screening
- Pregnancy or lactation; positive pregnancy test
- Unprotected sexual intercourse with unsterilized male partner within 30 days prior to drug administration
- Participation in other clinical studies within 3 months prior or concurrent
- Alcohol consumption over 10 units per week in the last month or history of substance abuse
- Smoking more than 10 cigarettes per day currently or in past 6 months; unwillingness to refrain from smoking during hospitalization
- Consumption of alcohol, caffeine, or xanthine products within 7 days prior to drug intake
- Consumption of citrus fruits, cranberries, rose hips, St. John's wort products within 7 days prior to drug intake
- Dehydration within 24 hours prior to drug intake
- Positive tests for HIV, syphilis, hepatitis B or C, SARS-CoV-2
- ECG abnormalities
- Positive urine tests for narcotics or potent medications
- Positive breath alcohol test
- Planned hospitalization other than study-related
- Inability or unwillingness to comply with protocol or dietary restrictions
- Membership in vulnerable populations or other conditions preventing study participation
- Dental procedures within 3 weeks prior to screening
- Other investigator judgment reasons preventing participation or causing withdrawal
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia, 196143
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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