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An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray Compared to Lozenges in Healthy Volunteers
Led by Valenta Pharm JSC · Updated on 2025-07-10
24
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes two forms of Grammidin with anesthetic in healthy adults aged 18 to 45. This study compares a metered dose topical spray to lozenges after a single dose to understand their pharmacokinetics and side effects. The trial is sponsored by Valenta Pharm JSC and is a Phase 1 interventional study involving healthy volunteers. Participants receive either the Grammidin with anesthetic neo lozenge, taken once with food, or the Grammidin with anesthetic topical spray, consisting of four sprays taken once with food. The study uses a randomized design where volunteers receive both treatments in different sequences with a washout period between them. The treatments are evaluated in two sequences: one starting with lozenges followed by spray, and the other with spray followed by lozenges. Volunteers take part in the study for approximately 15 days, including screening before the study and follow-up visits. During the study, researchers monitor pharmacokinetic parameters such as peak drug concentration and elimination rates over 24 hours after each dose. Safety is closely observed through physical exams, vital signs, ECGs, blood and urine tests, and recording any adverse events. Researchers also track volunteer complaints and overall tolerability during this period.
CONDITIONS
Brief 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
- Males and females aged 18 to 45 years
- Verified healthy status with no clinically significant abnormalities in medical history, physical exam, or lab tests
- Blood pressure: systolic 99-129 mm Hg and 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°C to 36.9°C
- Body mass index between 18.5 and 30 kg/m², with minimum weight ≥55 kg for men and ≥45 kg for women
- Consent to use effective contraception during the study and for 30 days after completion, with negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of significant allergies or hypersensitivity to study drugs or excipients
- Chronic diseases affecting kidneys, liver, gastrointestinal, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or eyes
- Oral mucosa lesions or damage
- Recent gastrointestinal surgery except appendectomy over one year ago
- Acute infections within 4 weeks prior to screening
- Use of medications affecting liver or hemodynamics within 2 months prior to screening
- Regular or recent use of medications or supplements within 2 weeks prior to screening
- Blood or plasma donation within 3 months prior to screening
- Use of hormonal contraceptives or depot injections within specified timeframes
- Pregnancy or lactation; positive pregnancy test
- Unprotected sex with unsterilized male partner within 30 days prior to drug administration
- Participation in another clinical study within 3 months prior or concurrent
- Excessive alcohol consumption or substance abuse history
- Smoking more than 10 cigarettes per day currently or in past 6 months
- Consumption of alcohol, caffeine, citrus fruits, cranberry, rose hips, St. John's wort within 7 days prior to dosing
- Dehydration within 24 hours prior to dosing
- Positive tests for HIV, syphilis, hepatitis B or C, SARS-CoV-2, narcotics, or alcohol
- ECG abnormalities
- Planned hospitalization unrelated to study
- Inability or unwillingness to follow protocol, including diet and activity restrictions
- Membership in vulnerable populations
- Recent dental procedures within 3 weeks prior to screening
- Other conditions or lifestyles that may affect study participation or adherence
- Withdrawal or non-compliance during study
- Severe adverse events or treatments affecting pharmacokinetics during study
- Missed blood sample collections
- Vomiting or diarrhea within 6 hours after dosing
- Positive pregnancy or SARS-CoV-2 test during study
- Any other reasons preventing protocol adherence or study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
Visits occur during screening period for assessments and tests
Duration - Approximately 15 days
Participants receive two different drug interventions in a randomized crossover design to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits for drug administration and pharmacokinetic sampling over 15 days
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
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