Healthy VolunteersPhase 1NCT01859377
Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations
A Phase 1 study testing V0498 - A mg and Ibuprofen in people with Healthy Volunteers, run by Pierre Fabre Medicament at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- V0498 - A mg and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Jun 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject aged 18 to 45 years (inclusive),
- 18.5 < or = Body Mass Index < or = 30 kg/m²,
- Non-smoker for at least 6 months
- Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .
Who cannot join
- Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,
- Organic disorder likely to modify absorption, distribution or elimination of the medication,
- History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients
- Subject who has donated blood within the past 3 months,
- Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,
- Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.
- Conditions
- Healthy Volunteers
- Being tested
- V0498 - A mg, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0498 - A mgDrug
Single oromucosal administration
IbuprofenDrug
Single oral administration
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Test Drug (V0498 - A mg) - Reference (Ibuprofen) Receives: Drug: V0498 - A mg; Drug: Ibuprofen |
| Sequence 2 | Other | Reference (Ibuprofen) - Test drug(V0498 - A mg) Receives: Drug: V0498 - A mg; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: 11 time points up to 10h after administration
Time of Maximum Concentration
Measured: 11 time points up to 10h after administration
Area Under Curve (AUC0-72)
Measured: 11 time points up to 10h after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859377
- Sponsor's protocol ID
- V00498 TA 1 01
- Other IDs
- 2013-000732-96
- Status last verified
- Jun 2013
- First submitted
- 17 May 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations
- ClinicalTrials.gov ID
- NCT01859377
- Acronym / sponsor ID
- V00498 TA 1 01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 May 2013 (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 evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: V0498 - A mg, Drug: IbuprofenTest Drug (V0498 - A mg) - Reference (Ibuprofen) |
| Sequence 2 | Other | Drug: V0498 - A mg, Drug: IbuprofenReference (Ibuprofen) - Test drug(V0498 - A mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subject aged 18 to 45 years (inclusive),
- 18.5 < or = Body Mass Index < or = 30 kg/m²,
- Non-smoker for at least 6 months
- Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .
Key exclusion criteria (6 listed)
- Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,
- Organic disorder likely to modify absorption, distribution or elimination of the medication,
- History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients
- Subject who has donated blood within the past 3 months,
- Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,
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 |
|---|---|---|
| V0498 - A mgSingle oromucosal administration | Drug | Sequence 1, Sequence 2 |
| IbuprofenSingle oral administration | Drug | Sequence 1, Sequence 2 |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 11 time points up to 10h after administration
Time of Maximum Concentration
Time frame: 11 time points up to 10h after administration
Area Under Curve (AUC0-72)
Time frame: 11 time points up to 10h after administration
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 24 Jun 2013.
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Screening Protocol
Pain
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 V0498 - A mg and Ibuprofen in people with Healthy Volunteers, run by Pierre Fabre Medicament at 1 site in Belgium.
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 4 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 24 Jun 2013. 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 Belgium. 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?
Maximum Plasma Concentration (Cmax) (time frame: 11 time points up to 10h after administration). 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?
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 24 Jun 2013.