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Palatability Study of Five Formulations of Benzydamine HCl Lozenges | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Palatability Study of Five Formulations of Benzydamine HCl Lozenges

NCT07199543•Aziende Chimiche Riunite Angelini Francesco S.p.A

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.

Eligibility

Age

6 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•To be enrolled in this study, adults must fulfil all these criteria:
•1. Informed consent: signed written informed consent before inclusion in the study
•2. Gender, age: any gender, 18-55 years old inclusive
•3. Body Mass Index: 18.5-30 kg/m2 inclusive
•4. 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
•5. 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
•6. Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception:
•1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
•2. 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
•3. A male sexual partner who agrees to use a male condom with spermicide
+17 more criteria

Exclusion Criteria

•Adults and minors meeting any of these criteria will not be enrolled in the study:
•1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
•2. 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
•3. 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
•4. 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
•5. 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
•6. 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.
•Adults meeting any of these exclusion/withdrawal criteria:
•7. Drug, alcohol, caffeine, tobacco: history of (within the past 12 months) or current drug, alcohol, caffeine or tobacco abuse
•8. Positive result at the urine drug test at screening or at visit 3
+6 more criteria

Locations (1)

CROSS Research S.A. - Phase I Unit

Arzo, Switzerland, Switzerland

Key Dates

Start Date

April 13, 2025

Primary Completion Date

July 20, 2025

Completion Date

July 20, 2025

Last Updated

September 30, 2025

Enrollment

120

ACTUAL participants

Conditions

Healthy VolunteersPalatabilityTo Test the Palatability of a New Flavour and Four Commercially Available Flavours

Interventions

benzydamine HCl

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Palatability Study of Five Formulations of Benzydamine HCl Lozenges

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Single-dose,First-in-human of KLA478