Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers
NCT06857890 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-07-10
Summary
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
- Pharyngitis
Interventions
- DRUG
-
Grammidin with anesthetic neo
Grammidin with anesthetic neo, lozenges, 1 lozenge to be taken once under fed conditions.
- DRUG
-
Grammidin with anesthetic, a metered dose topical spray
Grammidin with anesthetic, a metered dose topical spray, 4 sprays to be taken once under fed conditions
Sponsors & Collaborators
-
Valenta Pharm JSC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-09
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
Countries
- Russia
Study Locations
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