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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
120
The investigational medicinal products were tasted during two study ambulatory visits, separated by a wash-out of at least 3 days
CROSS Research S.A. - Phase I Unit
Arzo, Switzerland, Switzerland
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
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