Healthy SmokersPhase 1NCT02089308
Nicotine Patch - Bioequivalence Study
A Phase 1 study testing Test treatment : V0116 transdermal patch and Reference treatment : Nicotine transdermal patch in people with Healthy Smokers, run by Pierre Fabre Medicament at 1 site in France.
Trial summary
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications 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 Smokers
- What is being tested?
- Test treatment : V0116 transdermal patch and Reference treatment : Nicotine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to May 2014
- 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)
- Current Smoker of >or = 5 and < or = to 15 cigarettes/day
- Fagerström score < or =5 at selection
- Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.
Who cannot join
- Presence of any significant medical findings 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 safety assessment of a transdermal patch
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
- Conditions
- Healthy Smokers
- Being tested
- Test treatment : V0116 transdermal patch, Reference treatment : Nicotine transdermal patch
- 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.
Test treatment : V0116 transdermal patchDrug
Reference treatment : Nicotine transdermal patchDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Sequence 1 | Other | Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. Receives: Drug: Test treatment : V0116 transdermal patch; Drug: Reference treatment : Nicotine transdermal patch |
| Treatment-Sequence 2 | Other | Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. Receives: Drug: Test treatment : V0116 transdermal patch; Drug: Reference treatment : Nicotine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: During the third application of each period,12 time points up to 24h after the application
Time to Maximum Concentration (Tmax)
Measured: During the third application of each period,12 time points up to 24h after the application
Area under the plasma concentration-time curve (AUC)
Measured: During the third application of each period, 12 time points up to 24h after the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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
- 74 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
- NCT02089308
- Sponsor's protocol ID
- V00116 TD 1 06
- Other IDs
- 2013-005290-47
- Status last verified
- Jun 2014
- First submitted
- 13 Mar 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Patch - Bioequivalence Study
- ClinicalTrials.gov ID
- NCT02089308
- Acronym / sponsor ID
- V00116 TD 1 06
- Conditions
- Healthy Smokers
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Mar 2014 (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 bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-Sequence 1 | Other | Drug: Test treatment : V0116 transdermal patch, Drug: Reference treatment : Nicotine transdermal patchSubjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. |
| Treatment-Sequence 2 | Other | Drug: Test treatment : V0116 transdermal patch, Drug: Reference treatment : Nicotine transdermal patchSubjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. |
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)
- Current Smoker of >or = 5 and < or = to 15 cigarettes/day
- Fagerström score < or =5 at selection
- Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.
Key exclusion criteria (2 listed)
- Presence of any significant medical findings 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 safety assessment of a 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 |
|---|---|---|
| Test treatment : V0116 transdermal patch | Drug | Treatment-Sequence 1, Treatment-Sequence 2 |
| Reference treatment : Nicotine transdermal patch | Drug | Treatment-Sequence 1, Treatment-Sequence 2 |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: During the third application of each period,12 time points up to 24h after the application
Time to Maximum Concentration (Tmax)
Time frame: During the third application of each period,12 time points up to 24h after the application
Area under the plasma concentration-time curve (AUC)
Time frame: During the third application of each period, 12 time points up to 24h after the application
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 12 Jun 2014.
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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 Test treatment : V0116 transdermal patch and Reference treatment : Nicotine transdermal patch 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 12 Jun 2014. 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?
Maximum Plasma Concentration (Cmax) (time frame: During the third application of each period,12 time points up to 24h after the application). 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 12 Jun 2014; AzTrials last refreshed its copy on 27 Oct 2026.