HealthyPhase 1NCT00921830
Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories
A Phase 1 study testing ibuprofen in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Ireland.
Trial summary
The purpose of this study is to compare the pharmacokinetic and bioavailability characteristics of two test formulations of ibuprofen for rectal administration with the profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2004to Nov 2004
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged between 18 and 55 years
- BMI < 27 kg/m2
- Non-smokers, or smokers of less than 10 cigarettes per day
- Clinically normal vital signs
- Clinically normal medical history
- Clinically normal findings on physical examination
Show all 13Show fewer
- Clinically normal findings for haematology and clinical chemistry of blood and urine or showing clinically insignificant deviations only
- Screening results for drug abuse (taken within 14 days of study start) must be negative for opiates, cannabinoids, amphetamines, methamphetamine, benzodiazepines and cocaine
- HIV and Hepatitis B and C tests, taken within previous 14 days of study start, must be negative
- Appropriate use of an effective method of contraception (female volunteers only). Use of the oral contraceptive pill is permitted
- Ability to comprehend and communicate effectively with the Investigator and staff
- Ability to give written informed consent
- Electrocardiogram recording (12-lead) within the normal range
Who cannot join
- History of peptic ulcer or gastrointestinal bleeding
- Resting heart rate outside the range 50 - 90 beats per minute or exhibiting any clinically significant degree of heart block
- Resting, seated blood pressure less than 100/60 (90/50 for females) or greater than 140/90 mmHg
- Clinically significant electrolyte imbalance
- Evidence of clinically significant cardiovascular, haematological, hepatic, gastrointestinal, renal, respiratory, neurological, or psychiatric disease
- History of medication with any psycho-pharmacologically active agents within the last five years (other than occasional night sedatives)
Show all 29Show fewer
- Gastric bleeding or history of allergies to NSAIDs
- History of psychiatric illness or clinical treatment for psychiatric illness within the last five years
- History of epilepsy
- History of significant drug or drug related hypersensitivity/intolerance or food allergies
- Illness within 14 days prior to start of study
- Hospitalisation within the previous 3 months for major surgery or significant medical illness (at the discretion of the Investigator)
- Mental handicap as defined by clinical evaluation
- Tobacco smoking of more than 10 cigarettes per day
- Participation in a clinical drug study in which blood was taken within 16 weeks prior to the start of the study
- Donation of blood or plasma within previous 90 days
- Participation in a clinical trial in the previous 12 months in which a volume of blood exceeding 500 ml was donated
- Any indication of current or previous abuse of alcohol, solvents or drugs
- Treatment with a full or regular course of medication during the 28 days prior to the start of the study
- Use of alcohol on study days or within 24 hours prior to commencement of each study period
- Intake of grapefruit products within 7 days prior to study commencement
- Intake of methylxanthine-containing beverages within 24 hours prior to each study period
- Intake of quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (habitually taking more than 5 cups or glasses of tea, coffee, cola, chocolate etc per day or habitually taking more than 20g alcohol/day)
- Taking medication (prescription or proprietary) within 14 days prior to the study start. Paracetamol is allowed up to 72 hours prior to either study period. The oral contraceptive pill is allowed.
- Failure to use adequate contraceptive measures; positive pregnancy test (female volunteers only)
- Lactating/breastfeeding (female volunteers only)
- Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegans)
- Not able/not willing to give informed consent
- Not able to be contacted in case of emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Three Formulations of Ibuprofen in Healthy, Fasting Male and Female Volunteers
The purpose of this study is to compare the pharmacokinetic and bioavailability characteristics of two test formulations of ibuprofen for rectal administration with the profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).
Read the detailed description
Ibuprofen is a widely used analgesic and antipyretic in adults and children. Two ibuprofen suppository formulations have been developed for pediatric use to facilitate dosing in younger age groups. This is a single-dose, balanced, randomised, three-period crossover study in healthy male and female adult volunteers. Each volunteer will receive a single dose of 50 mg ibuprofen as a suppository, a single dose of 200 mg ibuprofen as a suppository and a single oral dose of 200 mg ibuprofen (tablet). There will be 14 blood samples taken over 12 hours in each study period. Concentrations in plasma of ibuprofen and its S and R enantiomers will be measured using a validated chromatographic method. Standard pharmacokinetic parameters will be obtained and bioavailability on the basis of rate and extent of drug absorption will be assessed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
Also called MOTRIN®
Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | ibuprofen Receives: Drug: ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters, including AUC0-t and AUC0-∞
Measured: 14 samples over 12 hours in each period
Secondary outcomes (1)
Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant
Measured: 14 samples over 12 hours in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startApr 2004
- Primary completionJul 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Cottrell, Study director, McNeil UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921830
- Sponsor's protocol ID
- SCO2203
- Status last verified
- Oct 2011
- First submitted
- 15 Jun 2009
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Three Formulations of Ibuprofen in Healthy, Fasting Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00921830
- Acronym / sponsor ID
- SCO2203
- Conditions
- Healthy
- Keywords
- ibuprofen, healthy volunteers, bioavailability, pharmacokinetics, suppository
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 16 Jun 2009 (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 is to compare the pharmacokinetic and bioavailability characteristics of two test formulations of ibuprofen for rectal administration with the profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).
Detailed description
Ibuprofen is a widely used analgesic and antipyretic in adults and children. Two ibuprofen suppository formulations have been developed for pediatric use to facilitate dosing in younger age groups. This is a single-dose, balanced, randomised, three-period crossover study in healthy male and female adult volunteers. Each volunteer will receive a single dose of 50 mg ibuprofen as a suppository, a single dose of 200 mg ibuprofen as a suppository and a single oral dose of 200 mg ibuprofen (tablet). There will be 14 blood samples taken over 12 hours in each study period. Concentrations in plasma of ibuprofen and its S and R enantiomers will be measured using a validated chromatographic method. Standard pharmacokinetic parameters will be obtained and bioavailability on the basis of rate and extent of drug absorption will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: ibuprofenibuprofen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male and female volunteers aged between 18 and 55 years
- BMI < 27 kg/m2
- Non-smokers, or smokers of less than 10 cigarettes per day
- Clinically normal vital signs
- Clinically normal medical history
Key exclusion criteria (29 listed)
- History of peptic ulcer or gastrointestinal bleeding
- Resting heart rate outside the range 50 - 90 beats per minute or exhibiting any clinically significant degree of heart block
- Resting, seated blood pressure less than 100/60 (90/50 for females) or greater than 140/90 mmHg
- Clinically significant electrolyte imbalance
- Evidence of clinically significant cardiovascular, haematological, hepatic, gastrointestinal, renal, respiratory, neurological, or psychiatric disease
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 |
|---|---|---|
| ibuprofenAlso: MOTRIN®Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast. | Drug | Ibuprofen |
Primary outcome
Pharmacokinetic parameters, including AUC0-t and AUC0-∞
Time frame: 14 samples over 12 hours in each period
1 secondary outcome
Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant
Time frame: 14 samples over 12 hours in each period
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 6 Oct 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Jerry Cottrell study director
McNeil UK
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 in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Ireland.
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 13 inclusion and 29 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 6 Oct 2011. 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 Ireland. 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?
Pharmacokinetic parameters, including AUC0-t and AUC0-∞ (time frame: 14 samples over 12 hours in each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2011.