At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Ibuprofen+caffeine FDC +2 moredrug
Likely dose
Not stated in 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.
Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®), and 1 other intervention for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionJul 2013
TodayJul 2026
First PostedJun 17, 2013
Enrollment StartJun 1, 2013
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.0 years ago
Interventions
Ibuprofen+caffeine FDCdrug
oral dose
Ibuprofen (Nurofen Immedia®)drug
oral dose
Ibuprofen (Brufen®)drug
oral dose