Healthy Volunteer StudyPhase 1NCT02503085

Ibuprofen Suspension Bioequivalence Study

A Phase 1 study testing Nurofen for Children® and Algifor Dolo Junior® in people with Healthy Volunteer Study, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.

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

The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: Nurofen for Children® and Algifor Dolo Junior®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited Kingdom
Study dates: 2 Jun 2015to 25 Aug 2015
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

Subjects who have given written informed consent.
Age: ≥18 years ≤50 years.
Sex: Male or female subjects are eligible for entry.
Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
Female subject of non-child bearing potential with negative pregnancy test at the screening visit
Male subject willing to use an effective method of contraception, unless anatomically sterile
Status: Healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Healthy Subjects with a Body Mass Index (BMI) of ≥20 and ≤27 kg/m2

Who cannot join

Pregnancy or lactating female subjects.
A history of significant disease of any body system.
Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
A history of frequent dyspepsia, e.g. heartburn or indigestion.

Show all 21Show fewer

A history of migraine.
Current smokers and ex-smokers who have smoked within 6 months.
A history of drug abuse (including alcohol).
High consumption of stimulating drinks (caffeine intake per day above 300 mg).
Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
Ingestion of an over-the-counter preparation within 7 days before dosing with study medication.
Donation of blood in quantity in the previous 12 weeks before enrolment into the study.
Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
Topical use of ibuprofen within 7 days before dosing with study medication.
Those previously randomised into this study.
Employee at study site.
Partner or first degree relative of the Investigator.
Those who have participated in a clinical trial in the previous 12 weeks.
Those unable in the opinion of the Investigator to comply fully with the study requirements.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Reckit Benckiser
Hull

Other trials in United Kingdom

About this study

Official title: A Randomized, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic (PK) Study Comparing a 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Nurofen for Children®) With a Swiss Reference 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Algifor Dolo Junior®) in the Fed and Fasted States

The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.

Conditions: Healthy Volunteer Study
Being tested: Nurofen for Children®, Algifor Dolo Junior®
Keywords: Ibuprofen

What participants receive

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

Nurofen for Children®Drug
Also called Ibuprofen orange oral suspension
Algifor Dolo Junior®Drug
Also called Ibuprofen oral suspension

Study groups in NCT02503085
Study group	Role	What they receive
Nurofen for Children® (fasted)	Experimental	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition Receives: Drug: Nurofen for Children®
Nurofen for Children® (fed)	Experimental	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition Receives: Drug: Nurofen for Children®
Algifor Dolo Junior® (fasted)	Active comparator	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition Receives: Drug: Algifor Dolo Junior®
Algifor Dolo Junior® (fed)	Active comparator	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition Receives: Drug: Algifor Dolo Junior®

What is being measured

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

Maximum Plasma Concentration (Cmax)
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Secondary outcomes (7)

Elimination Rate Constant (Kel)
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
AUC From Administration to Infinity (AUC0-inf)
AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Ratio of AUC0-t/AUC0-inf (AUCR)
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Time to Cmax (Tmax)
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration Half-life (T1/2)
Terminal elimination half-life (T1/2) = ln(2)/Kel
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Cn was derived using linear interpolation from the 2 samples taken either side of the nominal time where there was a sampling time deviation. For concentrations that were missing due to blood samples not being taken Cn was not derived.
Measured: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Number of Subjects With Adverse Events (AEs).
Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.
Mild = AE did not limit usual activities; subject may have experienced slight discomfort.
Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.
Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.
Relationship to Investigational Medicinal Products (IMP)
Unassessable/Unclassified = Insufficient information to be able to make an assessment.
Conditional/ Unclassified = Insufficient information to make an assessment at present.
Unrelated = No possibility that AE was caused by IMP. Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. Certain = AE was definitely caused by IMP.
Measured: Up to follow-up day 7

Timeline

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

2 Jun 201525 Aug 2015

First posted20 Jul 2015 (estimated)
Study start2 Jun 2015
Primary completion25 Aug 2015
Study completion25 Aug 2015

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 Healthy Volunteer StudyStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02503085
Sponsor's protocol ID: NL1304
Other IDs: 2013-003366-14
Status last verified: Apr 2018
First submitted: 13 Jul 2015
Last updated: 13 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic (PK) Study Comparing a 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Nurofen for Children®) With a Swiss Reference 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Algifor Dolo Junior®) in the Fed and Fasted States
ClinicalTrials.gov ID: NCT02503085
Acronym / sponsor ID: NL1304
Conditions: Healthy Volunteer Study
Keywords: Ibuprofen
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
Study start: 2 Jun 2015 (actual)
Primary completion: 25 Aug 2015 (actual)
Study completion: 25 Aug 2015 (actual)
First posted: 20 Jul 2015 (estimated)
Results: Posted 13 Apr 2018

Clinical summary

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

The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Nurofen for Children® (fasted)	Experimental	Drug: Nurofen for Children®Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition
Nurofen for Children® (fed)	Experimental	Drug: Nurofen for Children®Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition
Algifor Dolo Junior® (fasted)	Active comparator	Drug: Algifor Dolo Junior®Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition
Algifor Dolo Junior® (fed)	Active comparator	Drug: Algifor Dolo Junior®Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition

Who may qualify

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

Key inclusion criteria (8 listed)

Subjects who have given written informed consent.
Age: ≥18 years ≤50 years.
Sex: Male or female subjects are eligible for entry.
Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
Female subject of non-child bearing potential with negative pregnancy test at the screening visit

Key exclusion criteria (21 listed)

Pregnancy or lactating female subjects.
A history of significant disease of any body system.
Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.

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
Nurofen for Children®Also: Ibuprofen orange oral suspension	Drug	Nurofen for Children® (fasted), Nurofen for Children® (fed)
Algifor Dolo Junior®Also: Ibuprofen oral suspension	Drug	Algifor Dolo Junior® (fasted), Algifor Dolo Junior® (fed)

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

7 secondary outcomes

Elimination Rate Constant (Kel)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
AUC From Administration to Infinity (AUC0-inf)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Ratio of AUC0-t/AUC0-inf (AUCR)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Time to Cmax (Tmax)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration Half-life (T1/2)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Number of Subjects With Adverse Events (AEs).
Time frame: Up to follow-up day 7

Results and safety

Results posted to the registry on 13 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1-BACD: Nurofen for Children® - Algifor Dolo Junior®	7	7
Sequence 2-DCAB: Nurofen for Children® - Algifor Dolo Junior®	7	7
Sequence 3-CBDA: Nurofen for Children® - Algifor Dolo Junior®	7	7
Sequence 4-ADBC: Nurofen for Children® - Algifor Dolo Junior®	7	7

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose). Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted) n = 27	Treatment A: Nurofen for Children® 400 mg/20 mL (Fed) n = 28	Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted) n = 27	Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed) n = 26
Value	37499.938 (8983.3020)	26207.273 (5788.1116)	34752.646 (5205.5859)	26377.382 (7496.1966)

Population analysed: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Primary outcome: Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)

Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose). Mean (Standard Deviation). Unit: min*ng/mL

Measure	Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted) n = 27	Treatment A: Nurofen for Children® 400 mg/20 mL (Fed) n = 28	Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted) n = 27	Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed) n = 26
Value	6139350.787 (1315534.5598)	5783712.850 (1251017.0271)	5912050.421 (1353655.3076)	5639716.354 (1533625.9496)

Population analysed: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to follow-up day 7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	0 of 28 (0%)	11 of 28 (39.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Nurofen for Children® and Algifor Dolo Junior® in people with Healthy Volunteer Study, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.

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 8 inclusion and 21 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 13 Apr 2018. 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 United Kingdom. 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 13 Apr 2018). 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?

Maximum Plasma Concentration (Cmax) (time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)). 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 NCT02503085.

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 13 Apr 2018.