Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
2 other identifiers
interventional
36
1 country
1
Brief 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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jun 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
November 16, 2016
CompletedNovember 16, 2016
September 1, 2016
1 month
June 13, 2013
September 27, 2016
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
AUC(0-inf)
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
Study Arms (3)
Ibuprofen (Brufen®)
ACTIVE COMPARATORfilm-coated tablet
Ibuprofen (Nurofen Immedia®)
ACTIVE COMPARATORfilm-coated tablet
Ibuprofen+caffeine
EXPERIMENTALfixed-dose-combination (FDC)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1335.2.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2013
First Posted
June 17, 2013
Study Start
June 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
November 16, 2016
Results First Posted
November 16, 2016
Record last verified: 2016-09