MedDataX Logo

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

NCT ID: NCT01879371

Last Updated: 2016-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ibuprofen (Brufen®)

film-coated tablet

Group Type ACTIVE_COMPARATOR

Ibuprofen (Brufen®)

Intervention Type DRUG

oral dose

Ibuprofen (Nurofen Immedia®)

film-coated tablet

Group Type ACTIVE_COMPARATOR

Ibuprofen (Nurofen Immedia®)

Intervention Type DRUG

oral dose

Ibuprofen+caffeine

fixed-dose-combination (FDC)

Group Type EXPERIMENTAL

Ibuprofen+caffeine FDC

Intervention Type DRUG

oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibuprofen+caffeine FDC

oral dose

Intervention Type DRUG

Ibuprofen (Nurofen Immedia®)

oral dose

Intervention Type DRUG

Ibuprofen (Brufen®)

oral dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1335.2.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-000990-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1335.2

Identifier Type: -

Identifier Source: org_study_id