HealthyPhase 1NCT01879371

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

A Phase 1 study testing Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®) and Ibuprofen (Brufen®) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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®). Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®) and Ibuprofen (Brufen®)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteGermany
Study dates: Jun 2013to Jul 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1335.2.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)

Conditions: Healthy
Being tested: Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®), Ibuprofen (Brufen®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ibuprofen+caffeine FDCDrug
oral dose
Ibuprofen (Nurofen Immedia®)Drug
oral dose
Ibuprofen (Brufen®)Drug
oral dose

Study groups in NCT01879371
Study group	Role	What they receive
Ibuprofen (Brufen®)	Active comparator	film-coated tablet Receives: Drug: Ibuprofen (Brufen®)
Ibuprofen (Nurofen Immedia®)	Active comparator	film-coated tablet Receives: Drug: Ibuprofen (Nurofen Immedia®)
Ibuprofen+caffeine	Experimental	fixed-dose-combination (FDC) Receives: Drug: Ibuprofen+caffeine FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jul 2013

First posted17 Jun 2013 (estimated)
Study startJun 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01879371
Sponsor's protocol ID: 1335.2
Other IDs: 2013-000990-66
Status last verified: Sep 2016
First submitted: 13 Jun 2013
Last updated: 16 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)
ClinicalTrials.gov ID: NCT01879371
Acronym / sponsor ID: 1335.2
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 17 Jun 2013 (estimated)
Results: Posted 16 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ibuprofen (Brufen®)	Active comparator	Drug: Ibuprofen (Brufen®)film-coated tablet
Ibuprofen (Nurofen Immedia®)	Active comparator	Drug: Ibuprofen (Nurofen Immedia®)film-coated tablet
Ibuprofen+caffeine	Experimental	Drug: Ibuprofen+caffeine FDCfixed-dose-combination (FDC)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

Any relevant deviation from healthy conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ibuprofen+caffeine FDCoral dose	Drug	Ibuprofen+caffeine
Ibuprofen (Nurofen Immedia®)oral dose	Drug	Ibuprofen (Nurofen Immedia®)
Ibuprofen (Brufen®)oral dose	Drug	Ibuprofen (Brufen®)

Primary outcome

AUC(0-tz)
Time frame: 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
Cmax
Time frame: 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

1 secondary outcome

AUC(0-inf)
Time frame: 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

Results and safety

Results posted to the registry on 16 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ibu + Caf / Ibu Acid / Ibu Lysinate	6	6
Ibu + Caf / Ibu Lysinate / Ibu Acid	6	6
Ibu Acid / Ibu Lysinate/ Ibu + Caf	6	6
Ibu Acid/ Ibu + Caf / Ibu Lysinate	6	6
Ibu Lysinate/ Ibu + Caf / Ibu Acid	6	6
Ibu Lysinate / Ibu Acid / Ibu + Caf	6	6

Primary outcome: AUC(0-tz)

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: μg*h/mL

Measure	Ibuprofen + Caffeine (FDC) Tablet n = 36	Ibuprofen Acid Film-coated Tablet n = 36	Ibuprofen Lysinate Film-coated Tablet n = 36
Value	133 (22.2)	124 (19.4)	122 (19.3)

Ibuprofen + Caffeine (FDC) Tablet vs Ibuprofen Acid Film-coated Tablet: Geometric mean ratio (net): 107.85 (90% CI 105.334 to 110.431)
Ibuprofen + Caffeine (FDC) Tablet vs Ibuprofen Lysinate Film-coated Tablet: Geometric mean ratio (net): 109.48 (90% CI 107.072 to 111.936)

Population analysed: Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.

Primary outcome: Cmax

Measure	Ibuprofen + Caffeine (FDC) Tablet n = 36	Ibuprofen Acid Film-coated Tablet n = 36	Ibuprofen Lysinate Film-coated Tablet n = 36
Value	31.0 (17.2)	31.1 (22.5)	44.0 (20.6)

Ibuprofen + Caffeine (FDC) Tablet vs Ibuprofen Acid Film-coated Tablet: Geometric mean ratio (net): 99.65 (90% CI 93.874 to 105.776)
Ibuprofen + Caffeine (FDC) Tablet vs Ibuprofen Lysinate Film-coated Tablet: Geometric mean ratio (net): 70.42 (90% CI 67.087 to 73.928)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: from up to 21 days prior to first drug administration until 30 days after end of trial, 64 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ibuprofen + Caffeine (FDC) Tablet	0 of 36 (0%)	2 of 36 (5.6%)	Not reported
Ibuprofen Acid Film-coated Tablet	0 of 36 (0%)	4 of 36 (11.1%)	Not reported
Ibuprofen Lysinate Film-coated Tablet	0 of 36 (0%)	1 of 36 (2.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®) and Ibuprofen (Brufen®) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-tz) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01879371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.