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New Paediatric Formulation of Tachipirina®

NCT06358586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Cross S.A.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni · CROSS Research S.A. - Phase I Unit,

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-09
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358586 on ClinicalTrials.gov