Healthy VolunteersPhase 1NCT07199543
Palatability Study of Five Formulations of Benzydamine HCl Lozenges
A Phase 1 study testing benzydamine HCl in people with Healthy Volunteers and Palatability, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Palatability, To Test the Palatability of a New Flavour and Four Commercially Available Flavours
- What is being tested?
- benzydamine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2025to 20 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be enrolled in this study, adults must fulfil all these criteria:
- Informed consent: signed written informed consent before inclusion in the study
- 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
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- 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.
- Signed written informed assent for 14-17 years old inclusive adolescents or written informed assent for 11-13 years old inclusive children or oral informed assent for 6-10 years old inclusive children
- Gender, age: any gender, 6-17 years old inclusive
- Body Mass Index: not classified as overweight based on the applicable body mass index chart for sex and age
- Vital signs: systolic blood pressure, diastolic blood pressure and heart rate within the normal ranges suitable for age measured after 5 min at rest in the sitting position
- Full comprehension: ability of the paediatric volunteer and parent/legal representative to comprehend the full nature and purpose of the study, including possible risks and side effects; ability of the paediatric volunteer and parent/legal representative to co-operate with the Investigator and to comply with the requirements of the entire study
- Contraception and fertility (females of child-bearing potential 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 abstinenc, lactational, amenorrhea, and withdrawal are not acceptable. For all females of child-bearing potential, pregnancy test result must be negative at screening and at visit 3.
Who cannot join
- 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
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- 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:
- 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.
- Adolescents/children (12-17 years old inclusive) meeting any of these exclusion/withdrawal criteria:
- 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.
- Children (6-11 years old inclusive) meeting any of these exclusion/withdrawal criteria:
- 7. 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- benzydamine HCl
- Keywords
- Palatability test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzydamine HClDrug
The investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: benzydamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 min after the investigational medicinal product ejection
Secondary outcomes (6)
Safety data after administration
Subjects' blood pressure and heart rate will be measured by the Investigator or his/her deputy after 5 min at rest (in sitting position) at screening and final visit/ETV. For adults, normality parameters are clearly defined in the inclusion criteria. For minors, the Investigator or his/her deputy will verify that the measured parameters will be within the normal ranges suitable for age.
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Safety data after administration
Physical examination: The physical examination will include subject's oral cavity inspection. Information about the physical examination will be recorded by the Investigator. Any abnormalities will be recorded. Significant findings/illnesses, reported after the start of the study and that meet the definition of an AE, will be recorded in the subject source documents.
Date of the physical examination, overall Investigator's interpretation (as normal or abnormal and, if abnormal, clinically significant or not clinically significant) and clinically significant abnormalities (if any) will be reported in the eCRF.
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Safety data after administration
Body weight and height: Body weight and height will be recorded at screening visit only. Subjects will be weighed (kg) lightly clothed without shoes. For adults, BMI will be calculated as weight [kg]/(height [m] x height [m]). For minors, BMI will be evaluated on the basis of the applicable body mass index chart for sex and age
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Subjects' blood pressure and heart rate will be measured by the Investigator or his/her deputy after 5 min at rest (in sitting position) at screening and final visit/ETV. For adults, normality parameters are clearly defined in the inclusion criteria. For minors, the Investigator or his/her deputy will verify that the measured parameters will be within the normal ranges suitable for age.
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Physical examination: The physical examination will include subject's oral cavity inspection. Information about the physical examination will be recorded by the Investigator. Any abnormalities will be recorded. Significant findings/illnesses, reported after the start of the study and that meet the definition of an AE, will be recorded in the subject source documents.
Date of the physical examination, overall Investigator's interpretation (as normal or abnormal and, if abnormal, clinically significant or not clinically significant) and clinically significant abnormalities (if any) will be reported in the eCRF.
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Body weight and height: Body weight and height will be recorded at screening visit only. Subjects will be weighed (kg) lightly clothed without shoes. For adults, BMI will be calculated as weight [kg]/(height [m] x height [m]). For minors, BMI will be evaluated on the basis of the applicable body mass index chart for sex and age
Measured: Minimum study duration for each subject will be 4 days, screening visit included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start13 Apr 2025
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199543
- Sponsor's protocol ID
- 030(F/b)MD21257
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability Study of Five Formulations of Benzydamine HCl Lozenges
- ClinicalTrials.gov ID
- NCT07199543
- Acronym / sponsor ID
- 030(F/b)MD21257
- Conditions
- Healthy Volunteers, Palatability, To Test the Palatability of a New Flavour and Four Commercially Available Flavours
- Keywords
- Palatability test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healthy adult | Experimental | Drug: benzydamine HClA single oral dose (one lozenge) of each investigational medicinal product was administered to healthy adult in two study periods |
| Group 2: Paediatric volunteers | Experimental | Drug: benzydamine HClA single oral dose (one lozenge) of each investigational medicinal product was administered to paediatric volunteers in two study periods |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (27 listed)
- Informed consent: signed written informed consent before inclusion in the study
- 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
Key exclusion criteria (16 listed)
- Adults and minors meeting any of these criteria will not be enrolled in the study:
- Adolescents/children (12-17 years old inclusive) meeting any of these exclusion/withdrawal criteria:
- 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.
- 7. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzydamine HClThe investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days | Drug | Group 1: Healthy adult, Group 2: Paediatric volunteers |
Primary outcome
Palatability of a new flavour
Time frame: 15 min after the investigational medicinal product ejection
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.
6 secondary outcomes
Safety data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Safety data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Safety data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Tolerability data after administration
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing benzydamine HCl in people with Healthy Volunteers and Palatability, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability of a new flavour (time frame: 15 min after the investigational medicinal product ejection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.