NCT07199543

Palatability Study of Five Formulations of Benzydamine HCl Lozenges

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 6 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a palatability study on 60 healthy adult and 60 healthy children with 5 different aroma of Lozenges. They will keep the lozenge in their mouth (without swallowing, chewing or breaking) for 10 seconds and then they will eject it. Palatability will be evaluated by the study participants 15 min after each investigational medicinal product ejection using a questionnaire. It will include common terms used to describe the formulation's taste, aftertaste and texture, and a hedonic 7-point facial scale used to quantitate the sensory experiences (i.e., pleasantness of the formulation taste, smell, aftertaste, texture and overall evaluation). A numeric score will be assigned for each provided reply.

Conditions

• Healthy Volunteers
• Palatability
• To Test the Palatability of a New Flavour and Four Commercially Available Flavours

Interventions

Type	Name	Description
DRUG	benzydamine HCl	The investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days

Timeline

• Start date: 2025-04-13
• Primary completion: 2025-07-20
• Completion: 2025-07-20
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: Switzerland