A Phase 1 interventional study of benzydamine HCl in Healthy Volunteers, Palatability and To Test the Palatability of a New Flavour and Four Commercially Available Flavours, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Completed at 1 site in Switzerland. Open to participants aged 6 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Phase 1, Interventional, and Other
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.
Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be enrolled in this study, adults must fulfil all these criteria:
and fertility (females only): females of must be using at least one of the following reliable methods of contraception:
Females of non-child-bearing potential or in 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
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:
Exclusion Criteria:
Adults and minors meeting any of these criteria will not be enrolled in the 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.
Adults meeting any of these exclusion/withdrawal criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single oral dose (one lozenge) of each investigational medicinal product was administered to healthy adult in two study periods
Drug: benzydamine HCl
A single oral dose (one lozenge) of each investigational medicinal product was administered to paediatric volunteers in two study periods
Drug: benzydamine HCl
The investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days
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.
Time frame: 15 min after the investigational medicinal product ejection
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Minimum study duration for each subject will be 4 days, screening visit included
Ran from Apr 2025 to primary completion in Jul 2025, 3 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benzydamine
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