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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ibuprofen (Brufen®); Drug: Ibuprofen (Nurofen Immedia®); Drug: Ibuprofen+caffeine FDC

• Registration Number: NCT01879371
• Lead Sponsor: Boehringer Ingelheim

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-09
• Results First Submitted: 2016-09-27
• Results First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Results First Posted: 2016-11-16
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ibuprofen (Brufen®)	Ibuprofen (Brufen®)	film-coated tablet
Ibuprofen (Nurofen Immedia®)	Ibuprofen (Nurofen Immedia®)	film-coated tablet
Ibuprofen+caffeine	Ibuprofen+caffeine FDC	fixed-dose-combination (FDC)

Primary Outcome Measures

Name	Time	Method
Cmax	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: maximum measured concentration of Ibuprofen in plasma
AUC(0-tz)	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	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

Secondary Outcome Measures

Name	Time	Method
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	AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

1335.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany