At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Nurofen for Children® +1 moredrug
Likely dose
Nurofen for Children® 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic Study Comparing a 4% (w/v) Suspension of Ibuprofen With a Reference 2% (w/v) Suspension of Ibuprofen in the Fed and Fasted States.
In Brief
A Phase 1 clinical trial evaluating Nurofen for Children® and Algifor® Junior for Bioequivalence of the Test Formulation. Completed, enrolled 24 participants.
Detailed Summary
Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence of the Test Formulation
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
Primary CompletionMay 2016
First PostedApr 2018
TodayJul 2026
First PostedApr 12, 2018
Enrollment StartFeb 29, 2016
Primary CompletionMay 6, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago
Interventions
Nurofen for Children®drug
Nurofen for Children® 400 mg/10 ml
Algifor® Juniordrug
Algifor® Junior 400 mg/20 ml