NCT06358586

New Paediatric Formulation of Tachipirina®

Palatability Study of a Novel Paediatric Formulation of Tachipirina® With Strawberry Flavour

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tachipirina® 120 mg/5 mL oral suspension, new flavour	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.

Timeline

• Start date: 2022-04-09
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Switzerland