Actively Recruiting
An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers
Led by Valenta Pharm JSC · Updated on 2025-07-10
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes Grammidin, a metered dose topical spray, compared to Grammidin lozenges after a single dose in healthy adults. This Phase 1 trial focuses on healthy volunteers aged 18 to 45 years to better understand the pharmacokinetic profile of these formulations. Participants will receive either Grammidin neo lozenges or Grammidin spray in a randomized sequence, with one group taking lozenges followed by spray and the other group receiving spray followed by lozenges. The treatments are administered once under fed conditions to assess differences between the two forms. During the study, volunteers will undergo various assessments including physical exams, vital signs, blood and urine tests, ECGs, and monitoring for adverse events from screening through 15 days after dosing. Researchers will measure pharmacokinetic parameters such as peak concentration, time to peak, area under the curve, and elimination rate to evaluate drug absorption and clearance. Safety and tolerability will be closely monitored throughout the trial period.
CONDITIONS
Brief 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...
- Voluntarily signed informed consent before any study procedures
- Males and females aged 18 to 45 years inclusive
- Verified healthy status with no significant medical issues
- Systolic blood pressure between 99 and 129 mm Hg
- Diastolic blood pressure between 70 and 89 mm Hg
- Heart rate between 60 and 89 beats per minute
- Respiratory rate between 12 and 20 breaths per minute
- Body temperature between 36.0C and 36.9C
- Body mass index between 18.5 and 30 kg/m
- Minimum body weight 255 kg for men and 245 kg for women
- Consent to use contraceptives and negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of significant allergies or drug intolerance
- Chronic diseases affecting kidneys, liver, heart, lungs, nervous or immune systems
- Lesions or injuries to the oral mucosa
- Recent gastrointestinal surgery except appendectomy over 1 year ago
- Acute infections within 4 weeks before screening
- Use of medications affecting liver or hemodynamics within last 2 months
- Regular medication use within 2 weeks or single use within 7 days before screening
- Blood or plasma donation within 3 months prior to screening
- Use of hormonal contraceptives within 2 months before screening
- Pregnancy, lactation, or unprotected sex within 30 days for women of childbearing potential
- Participation in another clinical trial within 3 months before or during this study
- Excessive alcohol or cigarette use recently
- Consumption of alcohol, caffeine, citrus fruits, or certain supplements within 7 days before dosing
- Dehydration within 24 hours before dosing
- Positive tests for HIV, hepatitis, syphilis, SARS-CoV-2, narcotics, or alcohol during screening
- ECG abnormalities or positive pregnancy test during screening
- Planned hospitalization outside study protocol
- Inability or unwillingness to comply with study requirements
- Membership in vulnerable populations or certain lifestyle restrictions
- Recent dental procedures within 3 weeks
- Other conditions that may affect study participation or lead to early withdrawal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 days
Participants receive two different forms of Grammidin drug treatments in a randomized crossover sequence with observation of safety and pharmacokinetics.
Multiple visits including baseline dosing and follow-up visits over 15 days
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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