Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate

Study Overview
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Brief Summary
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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®).

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ibuprofen+caffeine FDC
* Drug: Ibuprofen (Nurofen Immedia®)
* Drug: Ibuprofen (Brufen®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen (Brufen®)<br>film-coated tablet | Drug: Ibuprofen (Brufen®)<br>* oral dose<br>|
| Active Comparator: Ibuprofen (Nurofen Immedia®)<br>film-coated tablet | Drug: Ibuprofen (Nurofen Immedia®)<br>* oral dose<br>|
| Experimental: Ibuprofen+caffeine<br>fixed-dose-combination (FDC) | Drug: Ibuprofen+caffeine FDC<br>* oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-tz) | AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point | 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration | 
| Cmax | Cmax: maximum measured concentration of Ibuprofen in plasma | 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) | AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity | 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration |