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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000990-66 | EudraCT Number | EudraCT |
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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen (Brufen®) | Active Comparator | film-coated tablet |
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| Ibuprofen (Nurofen Immedia®) | Active Comparator | film-coated tablet |
|
| Ibuprofen+caffeine | Experimental | fixed-dose-combination (FDC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen+caffeine FDC | Drug | oral dose |
| |
| Ibuprofen (Nurofen Immedia®) |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
- Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1335.2.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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36 healthy male and female subjects (at least a third of each sex) were recruited from the volunteers' pool of the Human Pharmacology centre of BI Pharma GmbH & Co. KG, Ingelheim, Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibu + Caf / Ibu Acid / Ibu Lysinate | Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
oral dose |
|
| Ibuprofen (Brufen®) | Drug | oral dose |
|
| FG001 | Ibu + Caf / Ibu Lysinate / Ibu Acid | Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG002 | Ibu Acid / Ibu Lysinate/ Ibu + Caf | Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG003 | Ibu Acid/ Ibu + Caf / Ibu Lysinate | Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG004 | Ibu Lysinate/ Ibu + Caf / Ibu Acid | Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG005 | Ibu Lysinate / Ibu Acid / Ibu + Caf | Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| COMPLETED |
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| NOT COMPLETED |
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Treated Set (TS): included all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibu + Caf / Ibu Acid / Ibu Lysinate | Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG001 | Ibu + Caf / Ibu Lysinate / Ibu Acid | Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG002 | Ibu Acid / Ibu Lysinate/ Ibu + Caf | Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG003 | Ibu Acid/ Ibu + Caf / Ibu Lysinate | Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG004 | Ibu Lysinate/ Ibu + Caf / Ibu Acid | Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG005 | Ibu Lysinate / Ibu Acid / Ibu + Caf | Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | 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 |
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| Primary | Cmax | Cmax: maximum measured concentration of Ibuprofen in plasma | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 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 |
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| Secondary | 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 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | 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 |
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from up to 21 days prior to first drug administration until 30 days after end of trial, 64 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen + Caffeine (FDC) Tablet | 400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h | 0 | 36 | 2 | 36 | ||
| EG001 | Ibuprofen Acid Film-coated Tablet | 400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h | 0 | 36 | 4 | 36 | ||
| EG002 | Ibuprofen Lysinate Film-coated Tablet | Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h | 0 | 36 | 1 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Male |
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| The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested. | Geometric mean ratio (net) | 109.48 | 2-Sided | 90 | 107.072 | 111.936 | The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '. | No | Superiority or Other |
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