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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ibuprofen (Nurofen Immedia®); Drug: Ibuprofen (Brufen®); Drug: Ibuprofen+caffeine FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01879371

2013-000990-66 (EudraCT Number)

1335.2

Details and patient eligibility

About

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®).

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Ibuprofen (Brufen®)

Active Comparator group

Description:

film-coated tablet

Treatment:

Drug: Ibuprofen (Brufen®)

Ibuprofen (Nurofen Immedia®)

Active Comparator group

Description:

film-coated tablet

Treatment:

Drug: Ibuprofen (Nurofen Immedia®)

Ibuprofen+caffeine

Experimental group

Description:

fixed-dose-combination (FDC)

Treatment:

Drug: Ibuprofen+caffeine FDC