Actively Recruiting
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, 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 with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.
CONDITIONS
Official Title
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent before any study procedures
- Male or female aged 18 to 45 years inclusive
- Verified healthy status with no significant abnormalities in medical history, physical exam, lab tests, or other diagnostics
- 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 between 36.0�b0C and 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
- Consent to use contraception and negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of clinically significant allergies
- Hypersensitivity or intolerance to active or excipient substances in the study drugs
- Chronic diseases affecting kidneys, liver, gastrointestinal, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or eyes
- Erosive-ulcerative oral mucosa lesions or recent dental procedures
- Prior gastrointestinal surgery except appendectomy over 1 year ago
- Conditions affecting drug absorption, metabolism, or excretion
- Acute infections within 4 weeks before screening
- Use of medications affecting hemodynamics or liver less than 2 months before screening
- Recent use of any medications, vitamins, or supplements as specified
- Blood or plasma donation within 3 months
- Hormonal contraceptives use within 2 months
- Pregnancy, lactation, or positive pregnancy test
- Participation in another clinical study within 3 months
- Excessive alcohol consumption or smoking
- Positive tests for HIV, hepatitis, SARS-CoV-2, narcotics, or alcohol breath test
- ECG abnormalities
- Planning hospitalization unrelated to this study
- Inability or unwillingness to comply with protocol or dietary/activity restrictions
- Membership in vulnerable populations
- Other conditions or lifestyle factors judged by investigator to interfere with study compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Separate Medical Unit "CoMed" (LLC "Ligand Research")
Moscow, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here