HealthyPhase 1NCT03180879
Ibuprofen Bioavailability Study
A Phase 1 study testing Test - RB ibuprofen acid orodispersible tablets, Reference - RB Nurofen ibuprofen acid tablets and Comparator - Dolormin ibuprofen lysine tablets in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. 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?
- Test - RB ibuprofen acid orodispersible tablets, Reference - RB Nurofen ibuprofen acid tablets and Comparator - Dolormin ibuprofen lysine tablets
- 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 siteUnited Kingdom
- Study dates
- 10 Apr 2017to 13 Jun 2017
- 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
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 18.0 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
- Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
- 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 or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
Who cannot join
- Pregnant or lactating females.
- A history and/or presence of significant disease of any body system, including significant psychiatric disorders, parasuicide.
- 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-steriodal anti-inflammatory drugs (NSAIDs), or the excipients of the formulations
- A history of or active peptic or duodenal ulcers or gastrointestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
- A history of frequent dyspepsia, e.g. heartburn or indigestion.
Show all 23Show fewer
- A history of significant and frequent migraine.
- Current smokers or ex-smokers who have smoked or used nicotine replacement products during the 6 months prior to the first dose of study medication.
- A history of substance abuse (including alcohol).
- Consumption of foods or beverages containing caffeine (e.g. coffee, tea, cola and chocolate) above 300 mg caffeine per day, prior to 48 hours of each treatment period. (One cup of coffee equals approximately 50 mg caffeine).
- Those with positive test for drugs of abuse and alcohol.
- Ingestion of a prescribed drug at any time in the 14 days before the first dose of study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers 30 days prior to the first dose of study medication (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
- Ingestion of an over-the-counter preparation within 7 days before the first dose of study medication, including herbal medications, vitamins, fish oil supplements, ibuprofen and other NSAIDs.
- Those who have consumed grapefruit or grapefruit juice, pumelo or Seville oranges in the 7 days before the first dose of study medication.
- Donation of blood > 400 mL e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication.
- Known human immune deficiency virus (HIV) positive status, or a positive viral serology test.
- Topical use of ibuprofen within 7 days before the first dose of study medication.
- Strenuous physical exercise from 48 hours prior to first dose of study medication.
- Those previously randomised into this study.
- Those who are an employee at the study site.
- Those who are a partner or first degree relative of the Investigator.
- Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of study medication.
- Those unable in the opinion of the Investigator to comply fully with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Compare the Bioavailability of 400 mg Ibuprofen From 2 x 200 mg Ibuprofen Acid Orodispersable Tablets, 2x 200 mg Ibuprofen Acid Tablets and 2 x 342 mg Ibuprofen Lysine Tablets in Fasted Healthy Volunteers
This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups.
This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
- Conditions
- Healthy
- Being tested
- Test - RB ibuprofen acid orodispersible tablets, Reference - RB Nurofen ibuprofen acid tablets, Comparator - Dolormin ibuprofen lysine tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test - RB ibuprofen acid orodispersible tabletsDrug
RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.
Reference - RB Nurofen ibuprofen acid tabletsDrug
RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.
Comparator - Dolormin ibuprofen lysine tabletsDrug
Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Order: Test, Reference, Comparator Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
| 2 | Experimental | Treatment Order: Test, Comparator, Reference Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
| 3 | Experimental | Treatment Order: Reference, Test, Comparator Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
| 4 | Experimental | Treatment Order: Reference, Comparator, Test Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
| 5 | Experimental | Treatment Order: Comparator, Test, Reference Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
| 6 | Experimental | Treatment Order: Comparator, Reference, Test Receives: Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis 0-12hrs
Cmax - the maximum observed plasma concentration.
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis 0-12hrs
Secondary outcomes (8)
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis 0-12hrs
Cmax - the maximum observed plasma concentration.
The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis 0-12hrs
Kel - Elimination rate constant
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
AUC0-inf - Area under the plasma concentration-time curve from administration to infinity
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
AUCR - Ratio AUC0-t/AUC0-inf
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
Tmax - Time until Cmax is first achieved
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
T1/2 - Plasma concentration (elimination) half-life
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
Cn - The plasma concentration at each planned nominal time point.
Secondary endpoint for Test, Reference and Comparator products
Measured: PK Analysis 0-12hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start10 Apr 2017
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
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 HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180879
- Sponsor's protocol ID
- RB7-UK-1604
- Status last verified
- Apr 2017
- First submitted
- 17 May 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sugar D, Francombe D, da Silva T, Hanid S, Hutchings S. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers. Clin Ther. 2019 Aug;41(8):1486-1498. doi: 10.1016/j.clinthera.2019.04.040. Epub 2019 Jun 12.
PubMed 31202508
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Single Dose, Three-way Crossover Study to Compare the Bioavailability of 400 mg Ibuprofen From 2 x 200 mg Ibuprofen Acid Orodispersable Tablets, 2x 200 mg Ibuprofen Acid Tablets and 2 x 342 mg Ibuprofen Lysine Tablets in Fasted Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03180879
- Acronym / sponsor ID
- RB7-UK-1604
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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.
This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups.
This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Test, Reference, Comparator |
| 2 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Test, Comparator, Reference |
| 3 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Reference, Test, Comparator |
| 4 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Reference, Comparator, Test |
| 5 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Comparator, Test, Reference |
| 6 | Experimental | Drug: Test - RB ibuprofen acid orodispersible tablets, Drug: Reference - RB Nurofen ibuprofen acid tablets, Drug: Comparator - Dolormin ibuprofen lysine tabletsTreatment Order: Comparator, Reference, Test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 18.0 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
- Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
Key exclusion criteria (23 listed)
- Pregnant or lactating females.
- A history and/or presence of significant disease of any body system, including significant psychiatric disorders, parasuicide.
- 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-steriodal anti-inflammatory drugs (NSAIDs), or the excipients of the formulations
- A history of or active peptic or duodenal ulcers or gastrointestinal 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 |
|---|---|---|
| Test - RB ibuprofen acid orodispersible tabletsRB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral. | Drug | 1, 2, 3, 4, 5, 6 |
| Reference - RB Nurofen ibuprofen acid tabletsRB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral. | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator - Dolormin ibuprofen lysine tabletsDolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral. | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
Time frame: PK Analysis 0-12hrs
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Cmax - the maximum observed plasma concentration.
Time frame: PK Analysis 0-12hrs
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
8 secondary outcomes
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
Time frame: PK Analysis 0-12hrs
Cmax - the maximum observed plasma concentration.
Time frame: PK Analysis 0-12hrs
Kel - Elimination rate constant
Time frame: PK Analysis 0-12hrs
AUC0-inf - Area under the plasma concentration-time curve from administration to infinity
Time frame: PK Analysis 0-12hrs
AUCR - Ratio AUC0-t/AUC0-inf
Time frame: PK Analysis 0-12hrs
Tmax - Time until Cmax is first achieved
Time frame: PK Analysis 0-12hrs
T1/2 - Plasma concentration (elimination) half-life
Time frame: PK Analysis 0-12hrs
Cn - The plasma concentration at each planned nominal time point.
Time frame: PK Analysis 0-12hrs
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 5 Oct 2017.
- Derived from this study: PubMed 31202508Sugar D, Francombe D, da Silva T, Hanid S, Hutchings S. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers. Clin Ther. 2019 Aug;41(8):1486-1498. doi: 10.1016/j.clinthera.2019.04.040. Epub 2019 Jun 12.
- Individual participant dataSharing planned: No
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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.
Annelize Koch, MBBS principal investigator
Simbec Research
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 Test - RB ibuprofen acid orodispersible tablets, Reference - RB Nurofen ibuprofen acid tablets and Comparator - Dolormin ibuprofen lysine tablets in people with Healthy, 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 7 inclusion and 23 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 5 Oct 2017. 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?
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?
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t. (time frame: PK Analysis 0-12hrs). 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 NCT03180879, 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 5 Oct 2017.