Healthy SmokersPhase 1NCT01658202
Nicotine Patch Bioequivalence Study
A Phase 1 study testing V0116 transdermal patch (Test treatment ) and Nicotine transdermal patch (Reference Treatment ) in people with Healthy Smokers, run by Pierre Fabre Medicament at 1 site in France.
Trial summary
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation. 4 single 24hour applications separated by 48hour intervals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Smokers
- What is being tested?
- V0116 transdermal patch (Test treatment ) and Nicotine transdermal patch (Reference Treatment )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject aged 18 to 45 years (inclusive)
- Current Smoker of >or = 5 and < or = 15 cigarettes/day
- Fagerström score < or =5 at selection
- Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.
Who cannot join
- Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
- Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
4 single 24hour applications separated by 48hour intervals.
- Conditions
- Healthy Smokers
- Being tested
- V0116 transdermal patch (Test treatment ), Nicotine transdermal patch (Reference Treatment )
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0116 transdermal patch (Test treatment )Drug
Nicotine transdermal patch (Reference Treatment )Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h. Receives: Drug: V0116 transdermal patch (Test treatment ); Drug: Nicotine transdermal patch (Reference Treatment ) |
| Sequence 2 | Other | After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h. Receives: Drug: V0116 transdermal patch (Test treatment ); Drug: Nicotine transdermal patch (Reference Treatment ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile
Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations
Measured: Blood samples will be collected on Days 1, 3, 5 and 7
Secondary outcomes (1)
Clinical safety (reported adverse events)
General and local safety by evaluating the number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram, haematology and biochemistry
Measured: up to day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SmokersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT01658202
- Sponsor's protocol ID
- V00116 TD 1 04
- Other IDs
- 2011-006212-32
- Status last verified
- Dec 2012
- First submitted
- 31 Jul 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Patch Bioequivalence Study
- ClinicalTrials.gov ID
- NCT01658202
- Acronym / sponsor ID
- V00116 TD 1 04
- Conditions
- Healthy Smokers
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Aug 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.
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
4 single 24hour applications separated by 48hour intervals.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: V0116 transdermal patch (Test treatment ), Drug: Nicotine transdermal patch (Reference Treatment )After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h. |
| Sequence 2 | Other | Drug: V0116 transdermal patch (Test treatment ), Drug: Nicotine transdermal patch (Reference Treatment )After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subject aged 18 to 45 years (inclusive)
- Current Smoker of >or = 5 and < or = 15 cigarettes/day
- Fagerström score < or =5 at selection
- Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.
Key exclusion criteria (2 listed)
- Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
- Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch
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 |
|---|---|---|
| V0116 transdermal patch (Test treatment ) | Drug | Sequence 1, Sequence 2 |
| Nicotine transdermal patch (Reference Treatment ) | Drug | Sequence 1, Sequence 2 |
Primary outcome
Pharmacokinetic profile
Time frame: Blood samples will be collected on Days 1, 3, 5 and 7
Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations
1 secondary outcome
Clinical safety (reported adverse events)
Time frame: up to day 9
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 11 Dec 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.
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 V0116 transdermal patch (Test treatment ) and Nicotine transdermal patch (Reference Treatment ) in people with Healthy Smokers, run by Pierre Fabre Medicament at 1 site in France.
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 2 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 11 Dec 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 France. 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 profile (time frame: Blood samples will be collected on Days 1, 3, 5 and 7). 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 11 Dec 2012.