PainPhase 1NCT01555476
Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores
A Phase 1 study testing Ibuprofen in people with Pain, run by McNeil AB at 1 site in Sweden.
Trial summary
This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- 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
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Mar 2012
- 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
- Healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive.
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study.
- For females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study.
- For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
- Body Mass Index (BMI) within protocol-specified parameters.
- A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.
Who cannot join
- Evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results.
- Females: Pregnant or breast-feeding
- Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
- History of regular alcohol consumption outside the protocol-specified allowances.
- Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
- Relationship to persons involved directly with the conduct of the study, or their families.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Between an Ibuprofen Suspension and a Reference Formulation. A Study in Healthy Volunteers.
This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.
Read the detailed description
The study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. Two doses of study medication will be given as single doses on two separate treatment visits. A washout of at least 48 hours will separate the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Not yet marketed.
A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits
IbuprofenDrug
Also called Nurofen for Children Six Plus
A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits
| Study group | Role | What they receive |
|---|---|---|
| A-IBU | Experimental | A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits. Receives: Drug: Ibuprofen |
| B-IBU | Active comparator | A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration (Cmax), is the maximum (peak) concentration (amount of drug) measured in blood plasma after a dose administration.
Measured: During 12 hours post-dose
AUCt
Area under the plasma concentration-vs.-time curve from start of drug administration until last measured concentration (AUCt), is a measure of how much of the drug reaches the bloodstream during the sampling period.
Measured: During 12 hours post-dose
Secondary outcomes (5)
AUC∞
Area under the plasma concentration-vs.-time curve from start of drug administration and extrapolated to infinity (AUC∞), is a measure of how much of the drug ever reaches the bloodstream.
Measured: During 12 hours post-dose
tmax
The time at which maximum concentration is reached (tmax)
Measured: During 12 hours post-dose
Terminal Elimination Rate Constant (λz)
The terminal elimination rate constant (λz) describes the rate at which a drug is eliminated from the body.
Measured: During 12 hours post-dose
t½
Terminal half-life (t½) is the time required for the plasma concentration (as well as the amount of drug in the body) to fall by one-half.
Measured: During 12 hours post-dose
Mean Residence Time (MRT)
Mean residence time (MRT) is the mean time a drug molecule resides in the body.
Measured: During 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555476
- Sponsor's protocol ID
- IBUPAI1002
- Other IDs
- 2011-001570-26
- Status last verified
- Jul 2012
- First submitted
- 13 Mar 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Between an Ibuprofen Suspension and a Reference Formulation. A Study in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01555476
- Acronym / sponsor ID
- IBUPAI1002
- Conditions
- Pain
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Mar 2012 (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.
This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.
Detailed description
The study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. Two doses of study medication will be given as single doses on two separate treatment visits. A washout of at least 48 hours will separate the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-IBU | Experimental | Drug: IbuprofenA single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits. |
| B-IBU | Active comparator | Drug: IbuprofenA single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive.
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study.
- For females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study.
- For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
- Body Mass Index (BMI) within protocol-specified parameters.
Key exclusion criteria (6 listed)
- Evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results.
- Females: Pregnant or breast-feeding
- Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
- History of regular alcohol consumption outside the protocol-specified allowances.
- Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
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: Not yet marketed.A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits | Drug | A-IBU |
| IbuprofenAlso: Nurofen for Children Six PlusA single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits | Drug | B-IBU |
Primary outcome
Cmax
Time frame: During 12 hours post-dose
Maximum observed plasma concentration (Cmax), is the maximum (peak) concentration (amount of drug) measured in blood plasma after a dose administration.
AUCt
Time frame: During 12 hours post-dose
Area under the plasma concentration-vs.-time curve from start of drug administration until last measured concentration (AUCt), is a measure of how much of the drug reaches the bloodstream during the sampling period.
5 secondary outcomes
AUC∞
Time frame: During 12 hours post-dose
tmax
Time frame: During 12 hours post-dose
Terminal Elimination Rate Constant (λz)
Time frame: During 12 hours post-dose
t½
Time frame: During 12 hours post-dose
Mean Residence Time (MRT)
Time frame: During 12 hours post-dose
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 10 Jul 2012.
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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.
Elisabeth Kruse, PhD study director
McNeil AB
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 Pain, run by McNeil AB at 1 site in Sweden.
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 6 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 10 Jul 2012. 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 Sweden. 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?
Cmax (time frame: During 12 hours 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?
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 10 Jul 2012.