This is a single centre, single dose, single-arm, open-label, palatability study. The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product.
Twenty (20) healthy paediatric volunteers aged 6-17 years old inclusive will be enrolled in the study. The primary end-point is to assess the palatability of the new strawberry flavour after single dose administration of the Investigation Medicine Product (IMP) through a questionnaire. The secondary end-points is to monitor the safety and tolerability data after single dose administration of the Investigation Medicine Product (IMP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
A single oral dose of the Tachipirina® 120 mg/5 mL oral suspension(10 mL) will be administered to healthy paediatric volunteers under fasting conditions for at least 1 h before IMP administration until completion of palatability assessment.
CROSS Research S.A. - Phase I Unit,
Arzo, Switzerland
Palatability of new flavour - Taste (1)
Subject are asked: How do you describe the taste of this medication? The corresponding answer are sweet, salty, sour, bitter.
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Taste (2)
Subject are asked: How much do you like the taste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator 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
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Smell
Subject are asked: How much do you like the smell of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator 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
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (1)
Subject are asked: Do you feel an aftertaste after the administration of this medication? The corresponding answer are Yes or No.
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (2)
If Subjects reply Yes to the previous question they are asked: Do you describe the aftertaste of this medication? The corresponding answer are sweet, salty, sour, bitter.
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Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (3)
If Subjects replies Yes to the previous question they are asked: How much do you like the aftertaste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator 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
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Texture (mouthfeel)
Subject are asked: How do you describe the texture of this medication in the mouth? The corresponding answer are Thin, thick, gritty.
Time frame: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Overall
Subject are asked: In general, how much do you like this medication?The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator 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
Time frame: 15 minutes after investigational medicinal product administration
Treatment emergent adverse events (TEAEs)
Number of TEAEs after single dose administration of the investigational medicinal product.
Time frame: Through study completion, an average of 2 weeks.