A Phase 1 interventional study of Grammidin neo and Grammidin, a metered dose topical spray in Pharyngitis, sponsored by Valenta Pharm JSC. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Valenta Pharm JSC · Phase 1, Interventional, and Other
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 .
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 24 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RT sequence where R is Grammidin neo, lozenges and T is Grammidin, a metered dose topical spray
Drug: Grammidin neo · Drug: Grammidin, a metered dose topical spray
TR sequence where T is Grammidin, a metered dose topical spray and R is Grammidin neo, lozenges
Drug: Grammidin neo · Drug: Grammidin, a metered dose topical spray
Grammidin neo, lozenges, 1 lozenge to be taken once under fed conditions.
Also known as: gramicidin s, cetylpyridinium chloride
Grammidin, a metered dose topical spray, 4 sprays to be taken once under fed conditions.
Also known as: gramicidin s, cetylpyridinium chloride
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of gramicidin S and cetylpyridinium chloride. The same analytes would be used for other pharmacokinetic measures listed below.
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: From 0 hours after each drug intake (extrapolated to infinity).
Pharmacokinetics - AUCextr
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Time frame: From 0 hours after each drug intake (extrapolated to infinity).
Pharmacokinetics - t1/2
Elimination half-life (t1/2)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - kel
Elimination constant (kel)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - MRT
Mean residence time (MRT)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - Vd
Volume of distribution
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - CL
Clearance (CL)
Time frame: From 0 to 24 hours after each drug intake.
Pharmacokinetics - number of terminal timepoints
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Time frame: From 0 to 24 hours after each drug intake.
Adverse event type
Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event number
Number of adverse events registered during the study
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event severety
Severity of adverse events registered during the study
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Drop-outs associated with adverse events
The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Volunteer complaints
Description of complaints, recieved from volunteer
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Physical examination results - cardiovascular system
An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - respiratory system
An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - digestive tract
An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - endocrine system
An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - musculoskeletal system
An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - nervous system
An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - sensory systems
An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Physical examination results - skin/visible mucous membranes
An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Vital signs - systolic blood pressure
Systolic blood pressure (SBP, mmHg)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Vital signs - diastolic blood pressure
Diastolic blood pressure (DBP, mmHg)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Vital signs - heart rate
Heart rate (HR, bpm)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Vital signs - body temperature (Celsius temperature scale)
Body temperature (Celsius temperature scale)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
12-lead electrocardiogram (ECG) - corrected QT interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Clinical blood test - hemoglobin
Hemoglobin (g/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - hematocrit
Hematocrit (%)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - red blood cell count
Red blood cell count (cells/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - platelet count
Platelet count (cells/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - leukocyte count
Leukocyte count (cells/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - segmented neutrophils
Leukocyte formula (segmented neutrophils, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - eosinophils
Leukocyte formula (eosinophils, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - basophils
Leukocyte formula (basophils, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - specific gravity
Specific gravity of the urine
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - color
Color of the urine
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - transparency
Transparency of the urine
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - pH
pH of the urine
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - protein
Protein concentration (g/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - glucose
Glucose concentration (mmol/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - red blood cells
Red blood cell content (number in sight)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - white blood cells
White blood cell content (number in sight)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - epithelial cells
Epithelial cell content (number in sight)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - casts
Presence of casts (Yes/No)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - mucus
Presence of mucus (Yes/No)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis - bacteria
Presence of bacteria (Yes/No)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - glucose
Glucose concentration (mmol/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - protein
Total protein concentration (g/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - creatinine
Creatinine concentration (micromol/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Plan to share: No
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Studies of the drug tested here: Cetylpyridinium