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Palatability Study of Five Formulations of Benzydamine HCl Lozenges

NCT07199543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-30

No results posted yet for this study

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

DRUG

benzydamine HCl

The investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-13
Primary Completion
2025-07-20
Completion
2025-07-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199543 on ClinicalTrials.gov