Recruiting
PHASE1
INTERVENTIONAL
NCT06859281
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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 .
Interventions
Name:
Grammidin neo
Type:
DRUG
Description:
Grammidin neo, lozenges, 1 lozenge to be taken once under fed conditions.
Name:
Grammidin, a metered dose topical spray
Type:
DRUG
Description:
Grammidin, a metered dose topical spray, 4 sprays to be taken once under fed conditions.
Primary Outcomes
Measure:
Pharmacokinetics - Cmax
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Maximum plasma concentration (Cmax) of gramicidin S and cetylpyridinium chloride. The same analytes would be used for other pharmacokinetic measures listed below.
Measure:
Pharmacokinetics - tmax
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Time to reach Cmax (tmax)
Measure:
Pharmacokinetics - AUC0-t
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Measure:
Pharmacokinetics - AUC0-inf
TimeFrame:
From 0 hours after each drug intake (extrapolated to infinity).
Description:
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Measure:
Pharmacokinetics - AUCextr
TimeFrame:
From 0 hours after each drug intake (extrapolated to infinity).
Description:
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measure:
Pharmacokinetics - t1/2
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Elimination half-life (t1/2)
Measure:
Pharmacokinetics - kel
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Elimination constant (kel)
Measure:
Pharmacokinetics - MRT
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Mean residence time (MRT)
Measure:
Pharmacokinetics - Vd
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Volume of distribution
Measure:
Pharmacokinetics - CL
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Clearance (CL)
Measure:
Pharmacokinetics - number of terminal timepoints
TimeFrame:
From 0 to 24 hours after each drug intake.
Description:
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Trial Information
NCT ID
NCT06859281
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Valenta Pharm JSC
Last Updated
December 15, 2025