Phase 1
Completed N=36
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
Healthy
Source: ClinicalTrials.gov NCT01879371 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: AUC(0-tz) — 133; 124; 122 μg*h/mL
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®).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-tz) |
133; 124; 122 | — |
| PRIMARY Cmax |
31.0; 31.1; 44.0 | — |
| SECONDARY AUC(0-inf) |
135; 127; 125 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
- Age 18 to 50 years
- Body mass index (BMI) 18.5 to 29.9 kg/m2
- Subjects must be able to understand and comply with study requirements
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01879371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.