Trials / Completed
CompletedNCT03496324
Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nurofen for Children® | Nurofen for Children® 400 mg/10 ml |
| DRUG | Algifor® Junior | Algifor® Junior 400 mg/20 ml |
Timeline
- Start date
- 2016-02-29
- Primary completion
- 2016-05-06
- Completion
- 2016-05-06
- First posted
- 2018-04-12
- Last updated
- 2019-06-05
- Results posted
- 2019-06-05
Source: ClinicalTrials.gov record NCT03496324. Inclusion in this directory is not an endorsement.