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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-PK-21-356 | Other Identifier | CRO code |
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| Name | Class |
|---|---|
| Cross S.A. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tachipirina® 120 mg/5 mL oral suspension, strawberry flavour | Experimental | All healthy paediatric volunteers administered with the mediation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tachipirina® 120 mg/5 mL oral suspension, new flavour | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 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:
| 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. | 15 minutes after investigational medicinal product administration |
| Palatability of new flavour - Aftertaste (2) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events (TEAEs) | Number of TEAEs after single dose administration of the investigational medicinal product. | Through study completion, an average of 2 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milko Radicioni | CROSS Research S.A. - Phase I Unit, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research S.A. - Phase I Unit, | Arzo | CH-6864 | Switzerland |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Single centre, single dose, single-arm, open-label, palatability study
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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. |
| 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:
| 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. | 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:
| 15 minutes after investigational medicinal product administration |