Palatability Study of Five Formulations of Benzydamine HCl Lozenges

NCT07199543 | Completed Phase 1

• 1 other identifier: 030(F/b)MD21257
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Palatability test

Outcome Measures

Primary Outcomes (1)

• Palatability of a new flavour

  The palatability of a new flavour and four commercially available flavours of Benzydamine HCl 3 mg lozenges, tasted by healthy adult and paediatric volunteers 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 -Chen scale- in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences (i.e., pleasantness of the formulation taste, smell, aftertaste, texture and overall evaluation). For the Chen scale, a numeric score will be assigned by the Investigator to each provided reply, as follows: Very bad = 1, Bad = 2, Just a little bad = 3, Not sure = 4, Just a little good = 5, Good = 6, Very good = 7. Palatability evaluation scores will be listed and summarised using tables of frequency.

  15 min after the investigational medicinal product ejection

Secondary Outcomes (6)

• Safety data after administration

  Minimum study duration for each subject will be 4 days, screening visit included

• Safety data after administration

  Minimum study duration for each subject will be 4 days, screening visit included

• Safety data after administration

  Minimum study duration for each subject will be 4 days, screening visit included

• Tolerability data after administration

  Minimum study duration for each subject will be 4 days, screening visit included

• Tolerability data after administration

  Minimum study duration for each subject will be 4 days, screening visit included

Study Arms (2)

Group 1: Healthy adult

EXPERIMENTAL

A single oral dose (one lozenge) of each investigational medicinal product was administered to healthy adult in two study periods

Drug: benzydamine HCl

Group 2: Paediatric volunteers

EXPERIMENTAL

A single oral dose (one lozenge) of each investigational medicinal product was administered to paediatric volunteers in two study periods

Drug: benzydamine HCl

Interventions

benzydamine HCl DRUG

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

Group 1: Healthy adult; Group 2: Paediatric volunteers

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be enrolled in this study, adults must fulfil all these criteria:
• Gender, age: any gender, 18-55 years old inclusive
• Body Mass Index: 18.5-30 kg/m2 inclusive
• Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
• Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception:
• Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
• A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
• A male sexual partner who agrees to use a male condom with spermicide
• A sterile sexual partner
• True abstinence Periodic abstinence, lactational, amenorrhea, and withdrawal are not acceptable.
• Females of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.
• For all females, pregnancy test result must be negative at screening and at visit 3.
• To be enrolled in this study, minors must fulfil all these criteria:
• Informed consent and assent: signed written informed consent by at least one parent/legal representative.

You may not qualify if:

• Adults and minors meeting any of these criteria will not be enrolled in the study:
• Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
• Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; ascertained or presumptive hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; intolerance to some sugars; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the study participants safety
• Diseases: history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study, in particular phenylketonuria or asthma or both; nasopharyngitis, rhinitis, cold, dysosmia, dysgeusia, mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the Investigator's opinion
• Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study that may interfere with the aim of the study according to the Investigator's opinion. Hormonal contraceptives for child-bearing potential females will be allowed
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
• Diet: abnormal diets or substantial changes in eating habits in the 4 weeks before this study that may interfere with the aim of the study according to the Investigator's opinion.
• Drug, alcohol, caffeine, tobacco: history of (within the past 12 months) or current drug, alcohol, caffeine or tobacco abuse
• Positive result at the urine drug test at screening or at visit 3
• Positive alcohol saliva test at screening or at visit 3
• Pregnancy (females only): positive or missing pregnancy test at screening or at visit 3, pregnant or breastfeeding females.
• Drug, alcohol, caffeine, tobacco: history of or current drug or alcohol consumption and history of or current tobacco use, history of or current caffeine consumption 8. Drug test: positive result at the urine drug test at screening or at visit 3 9. Alcohol test: positive alcohol saliva test at screening or at visit 3 10. Pregnancy (females only): for post-menarche females, positive or missing pregnancy test at screening or at visit 3, pregnant or breast-feeding females.
• \. Drug, alcohol, caffeine, tobacco: history of or current drug, alcohol or coffee consumption or tobacco use 8. Pregnancy (females only): for post-menarche females, positive or missing pregnancy test at screening or at visit 3, pregnant or breast-feeding females.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Cross Research S.A.: collaborator

Study Sites (1)

CROSS Research S.A. - Phase I Unit

Arzo, Switzerland, Switzerland

Location

MeSH Terms

Interventions

Benzydamine

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 30, 2025
• Study Start: April 13, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CH (1)