Healthy Volunteer StudyPhase 1NCT02452450
Ibuprofen and Paracetamol Pharmacokinetic Study
A Phase 1 study testing Ibuprofen Acid, Ibuprofen Lysine and Ibuprofen Sodium in people with Healthy Volunteer Study, run by Reckitt Benckiser Healthcare (UK) Limited.
Trial summary
The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol 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?
- Ibuprofen Acid, Ibuprofen Lysine and Ibuprofen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age: > 18 to < 50 years.
- Sex: Male and 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, if applicable
- 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.
- Status: Healthy volunteers with a body mass index of >18 and <30 kg/m2.
- Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis.
- Subjects who have given written informed consent
Who cannot join
- Pregnant 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 (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, or the excipients of the formulations.
- A history of 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.
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- A history of migraine.
- A history of psychotic illness, attempted suicide or parasuicide.
- Current smokers and ex-smokers who have smoked within 6 months.
- A history of drug abuse (including alcohol).
- High consumption of stimulating drinks
- 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, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.
- 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 with an ibuprofen level > 10 ng/ml as determined at pre-study screening visit 2 (Part 2 (Pivotal Phase) of the study only).
- Those who are unwilling to consume gelatin of animal origin (Part 2 (Pivotal Phase) of the study only).
- 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.
About this study
The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.
- Conditions
- Healthy Volunteer Study
- Being tested
- Ibuprofen Acid, Ibuprofen Lysine, Ibuprofen Sodium, Ibuprofen Liquid Capsules, Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen AcidDrug
Ibuprofen LysineDrug
Ibuprofen SodiumDrug
Ibuprofen Liquid CapsulesDrug
ParacetamolDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen lysine | Experimental | Not described Receives: Drug: Ibuprofen Lysine |
| Ibuprofen sodium | Experimental | Not described Receives: Drug: Ibuprofen Sodium |
| Ibuprofen liquid capsules | Experimental | Not described Receives: Drug: Ibuprofen Liquid Capsules |
| Ibuprofen acid | Active comparator | Not described Receives: Drug: Ibuprofen Acid |
| Paracetamol | Active comparator | Not described Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the maximum concentration (Cmax) of the reference Ibuprofen
Measured: 0-4hr
Time to the first extrapolated non-zero concentration (Tlag)
Measured: 0-4hr
Time to the maximum concentration (Tmax)
Measured: 0-4hr
Secondary outcomes (7)
Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol
Measured: 0-4hr
Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol
Measured: 0-4hr
Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol
Measured: 0-4hr
Partial area under the curve (AUCs) at each nominal blood sampling time-point
Measured: 0-4hr
The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef)
Measured: 0-4hr
The plasma concentration at each planned nominal time-point (Cn)
Measured: 0-4hr
The maximum plasma concentration (Cmax)
Measured: 0-4hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452450
- Sponsor's protocol ID
- NL1307
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Miles L, Hall J, Jenner B, Addis R, Hutchings S. Predicting rapid analgesic onset of ibuprofen salts compared with ibuprofen acid: Tlag, Tlow, Tmed, and a novel parameter, TCmaxRef. Curr Med Res Opin. 2018 Aug;34(8):1483-1490. doi: 10.1080/03007995.2018.1466697. Epub 2018 Apr 27.
PubMed 29667449
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen and Paracetamol Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT02452450
- Acronym / sponsor ID
- NL1307
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
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 rates of absorption of Ibuprofen and Paracetamol formulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen lysine | Experimental | Drug: Ibuprofen Lysine |
| Ibuprofen sodium | Experimental | Drug: Ibuprofen Sodium |
| Ibuprofen liquid capsules | Experimental | Drug: Ibuprofen Liquid Capsules |
| Ibuprofen acid | Active comparator | Drug: Ibuprofen Acid |
| Paracetamol | Active comparator | Drug: Paracetamol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: > 18 to < 50 years.
- Sex: Male and 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, if applicable
- 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.
Key exclusion criteria (24 listed)
- Pregnant 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 (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, or the excipients of the formulations.
- A history of 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 |
|---|---|---|
| Ibuprofen Acid | Drug | Ibuprofen acid |
| Ibuprofen Lysine | Drug | Ibuprofen lysine |
| Ibuprofen Sodium | Drug | Ibuprofen sodium |
| Ibuprofen Liquid Capsules | Drug | Ibuprofen liquid capsules |
| Paracetamol | Drug | Paracetamol |
Primary outcome
Time to the maximum concentration (Cmax) of the reference Ibuprofen
Time frame: 0-4hr
Time to the first extrapolated non-zero concentration (Tlag)
Time frame: 0-4hr
Time to the maximum concentration (Tmax)
Time frame: 0-4hr
7 secondary outcomes
Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol
Time frame: 0-4hr
Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol
Time frame: 0-4hr
Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol
Time frame: 0-4hr
Partial area under the curve (AUCs) at each nominal blood sampling time-point
Time frame: 0-4hr
The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef)
Time frame: 0-4hr
The plasma concentration at each planned nominal time-point (Cn)
Time frame: 0-4hr
The maximum plasma concentration (Cmax)
Time frame: 0-4hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 29667449Miles L, Hall J, Jenner B, Addis R, Hutchings S. Predicting rapid analgesic onset of ibuprofen salts compared with ibuprofen acid: Tlag, Tlow, Tmed, and a novel parameter, TCmaxRef. Curr Med Res Opin. 2018 Aug;34(8):1483-1490. doi: 10.1080/03007995.2018.1466697. Epub 2018 Apr 27.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen Acid, Ibuprofen Lysine and Ibuprofen Sodium in people with Healthy Volunteer Study, run by Reckitt Benckiser Healthcare (UK) Limited.
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 24 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to the maximum concentration (Cmax) of the reference Ibuprofen (time frame: 0-4hr). The study lists 3 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 NCT02452450, which also lists 1 linked publication.
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 27 May 2015.