Tobacco DependencePhase 1NCT03259607

Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers

A Phase 1 study testing Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum and Nicorette Extra Mint 4mg Gum in people with Tobacco Dependence, run by McNeil AB at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Dependence
What is being tested?: Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum and Nicorette Extra Mint 4mg Gum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteChina
Study dates: 14 Aug 2017to 9 Jan 2018
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 subjects between the ages of 18 and 55 years, inclusive, and healthy female subjects between the ages of 18 and 45 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the Investigator or an authorized physician.
Smoking of at least 10 cigarettes daily for at least one year preceding inclusion.
Subjects will have a body mass index (BMI) between 19 and 25 (inclusive) kg/m2 and a body weight >50 kg.
Females of childbearing potential must have a negative pregnancy test at the screening visit.
Male or non-pregnant, non-lactating female agree to the contraceptive requirements including male's and female partner's use of a highly effective methods of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of the study drug).
A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study before participating in any study-specific procedures.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

Who cannot join

Use of medications other than contraceptives specified in Inclusion Criterion 4. Vitamins, dietary, and herbal supplements must be discontinued at least two days before the first dose of study medication.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, Human Immunodeficiency Virus (HIV) or syphilis.
Hypersensitivity to the ingredients/components of any of the IPs.
History of alcoholism, as judged by the Investigator, within the past 6 months preceding this study and/or presenting a positive respiratory alcohol test (breathalyzer) at the screening visit.
History of drug abuse or presenting a positive drug screening test for psychoactive drugs and narcotic substances at screening visit.
Treatment with an IP within 3 months preceding this study.

Show all 10Show fewer

Donation or loss of blood within 3 months preceding this study if the estimated lost blood volume equaled or exceeded 200 mL.
Impaired chewing capability as assessed by oral examination (e.g. dentures, significant oral ulceration) or impaired salivary secretion (e.g. Sicca syndrome). Piercing of tongue and lips is considered to impair oral function.
Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study.
Relationship to persons involved directly with the conduct of the study (i.e. PI; Sub investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson (J\&J) subsidiaries; and the families of each).

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Hospital, No.1
Beijing, 100730

Other trials in China

About this study

Official title: A Single Dose, Randomized, Four Period, Fasting, Crossover Study to Assess Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Mint Gum 2 and 4 mg - in Adult Healthy Male and Female Smokers

This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized mode. This verification is done in a so-called bioequivalence study, which means that the same amount of the same active substance (nicotine), in the same dosage form, for the same route of administration, and meeting the same or comparable standards is performed.

During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two test products are comparable to the reference products.

Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Read the detailed description

This is a single-center, randomized, single-dose open-label, cross-over study in 76 healthy males and females in total. The investigational products (IPs), i.e., Nicorette Extra Mint Gum 2 and 4 mg, and Nicorette Mint Gum 2 and 4 mg, will be given as single doses at separate treatment visits. Investigational treatments will be separated by at least 36 hours.

Blood samples for determination of nicotine will be drawn pre-dose (within 5 minutes of administering, i.e., start of chewing) and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

Used gums will be collected and analyzed to determine the amount of remaining nicotine.

Any Adverse Events (AEs) that may occur will be registered.

Conditions: Tobacco Dependence
Being tested: Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum, Nicorette Extra Mint 4mg Gum, Nicorette Mint 4 mg Gum
Keywords: Bioequivalence
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicorette Extra Mint 2 mg GumDrug
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Nicorette Mint 2 mg GumDrug
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Nicorette Extra Mint 4mg GumDrug
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Nicorette Mint 4 mg GumDrug
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Study groups in NCT03259607
Study group	Role	What they receive
Treatment A	Experimental	Nicorette Extra Mint 2 mg Gum Receives: Drug: Nicorette Extra Mint 2 mg Gum
Treatment B	Active comparator	Nicorette Mint 2 mg Gum Receives: Drug: Nicorette Mint 2 mg Gum
Treatment C	Experimental	Nicorette Extra Mint 4 mg Gum Receives: Drug: Nicorette Extra Mint 4mg Gum
Treatment D	Active comparator	Nicorette Mint 4 mg Gum Receives: Drug: Nicorette Mint 4 mg Gum

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax) of nicotine.
The maximum observed plasma concentration (Cmax).
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Area under the plasma concentration versus time curve (AUC∞) of nicotine.
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

Secondary outcomes (14)

The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.
The area under the plasma concentration versus time curves from start of drug administration until 48 hours (infinity).
Measured: Extrapolation from 12 hours after start of drug administration until 48 hours.
The time at which the maximum nicotine concentration (Cmax) occurs (Tmax).
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs.
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Determination of the terminal elimination rate constant (lambda_z) for nicotine.
The rate at which the drug is removed from the body system.
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The plasma half-life (t1/2) of nicotine.
The time taken for the nicotine plasma concentration to fall to half its original value.
Measured: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Amount of nicotine extracted from Nicorette Mint 2 mg gums.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
Measured: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Mint 4 mg gums.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
Measured: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 2 mg gums.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
Measured: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 4 mg gums.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
Measured: After 30 minutes of chewing.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product.
Percentage of subjects experiencing treatment-emergent adverse events by treatment, system organ class and preferred term.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product - by worst-case severity.
Percentage (%) of subjects experiencing treatment-emergent adverse events by treatment, system organ class, preferred term and severity.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with common treatment-emergent adverse events (AEs) after single-dose administration of Investigational product.
Percentage (%) of subjects with commonly reported treatment-emergent adverse events by system organ class and preferred term.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class and preferred term.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse event.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product - by worst-case severity.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class, preferred term and severity.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-emergent serious adverse events (SAEs).
Percentage (%) of subjects experiencing treatment-emergent serious adverse events.
Measured: From first dose received up to 2.5 weeks + 30 days follow up after study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 20179 Jan 2018

First posted23 Aug 2017
Study start14 Aug 2017
Primary completion25 Dec 2017
Study completion9 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tobacco DependenceStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: single-center, randomized, single-dose, open-label, cross-over study
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03259607
Sponsor's protocol ID: CO-160307090208-SCCT
Other IDs: 10258820NIK1001
Status last verified: Jan 2019
First submitted: 2 Aug 2017
Last updated: 3 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking

All Tobacco Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose, Randomized, Four Period, Fasting, Crossover Study to Assess Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Mint Gum 2 and 4 mg - in Adult Healthy Male and Female Smokers
ClinicalTrials.gov ID: NCT03259607
Acronym / sponsor ID: CO-160307090208-SCCT
Conditions: Tobacco Dependence
Keywords: Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: McNeil ABIndustry (pharma, biotech, devices)
Collaborators: Janssen (China) Research & Development Center
Study start: 14 Aug 2017 (actual)
Primary completion: 25 Dec 2017 (actual)
Study completion: 9 Jan 2018 (actual)
First posted: 23 Aug 2017 (actual)
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.

During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two test products are comparable to the reference products.

Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Detailed description

Used gums will be collected and analyzed to determine the amount of remaining nicotine.

Any Adverse Events (AEs) that may occur will be registered.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: single-center, randomized, single-dose, open-label, cross-over study

Arm	Type	Receives
Treatment A	Experimental	Drug: Nicorette Extra Mint 2 mg GumNicorette Extra Mint 2 mg Gum
Treatment B	Active comparator	Drug: Nicorette Mint 2 mg GumNicorette Mint 2 mg Gum
Treatment C	Experimental	Drug: Nicorette Extra Mint 4mg GumNicorette Extra Mint 4 mg Gum
Treatment D	Active comparator	Drug: Nicorette Mint 4 mg GumNicorette Mint 4 mg Gum

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy male subjects between the ages of 18 and 55 years, inclusive, and healthy female subjects between the ages of 18 and 45 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the Investigator or an authorized physician.
Smoking of at least 10 cigarettes daily for at least one year preceding inclusion.
Subjects will have a body mass index (BMI) between 19 and 25 (inclusive) kg/m2 and a body weight >50 kg.
Females of childbearing potential must have a negative pregnancy test at the screening visit.
Male or non-pregnant, non-lactating female agree to the contraceptive requirements including male's and female partner's use of a highly effective methods of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of the study drug).

Key exclusion criteria (10 listed)

Use of medications other than contraceptives specified in Inclusion Criterion 4. Vitamins, dietary, and herbal supplements must be discontinued at least two days before the first dose of study medication.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, Human Immunodeficiency Virus (HIV) or syphilis.
Hypersensitivity to the ingredients/components of any of the IPs.
History of alcoholism, as judged by the Investigator, within the past 6 months preceding this study and/or presenting a positive respiratory alcohol test (breathalyzer) at the screening visit.
History of drug abuse or presenting a positive drug screening test for psychoactive drugs and narcotic substances at screening visit.

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
Nicorette Extra Mint 2 mg GumA single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.	Drug	Treatment A
Nicorette Mint 2 mg GumA single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.	Drug	Treatment B
Nicorette Extra Mint 4mg GumA single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.	Drug	Treatment C
Nicorette Mint 4 mg GumA single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.	Drug	Treatment D

Primary outcome

Peak Plasma Concentration (Cmax) of nicotine.
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The maximum observed plasma concentration (Cmax).
Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Area under the plasma concentration versus time curve (AUC∞) of nicotine.
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).

14 secondary outcomes

The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.
Time frame: Extrapolation from 12 hours after start of drug administration until 48 hours.
The time at which the maximum nicotine concentration (Cmax) occurs (Tmax).
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Determination of the terminal elimination rate constant (lambda_z) for nicotine.
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The plasma half-life (t1/2) of nicotine.
Time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Amount of nicotine extracted from Nicorette Mint 2 mg gums.
Time frame: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Mint 4 mg gums.
Time frame: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 2 mg gums.
Time frame: After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 4 mg gums.
Time frame: After 30 minutes of chewing.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product - by worst-case severity.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with common treatment-emergent adverse events (AEs) after single-dose administration of Investigational product.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse event.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product - by worst-case severity.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-emergent serious adverse events (SAEs).
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion.

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 3 Jan 2019.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Tobacco Dependence

Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking

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.

Shi Aixin, M. Pharm principal investigator

BeiJing Hospital, No.1, Beijing, China.

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 Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum and Nicorette Extra Mint 4mg Gum in people with Tobacco Dependence, run by McNeil AB at 1 site in China.

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 10 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 3 Jan 2019. 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 China. 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?

Peak Plasma Concentration (Cmax) of nicotine. (time frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of 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?

On the ClinicalTrials.gov record for NCT03259607.

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 3 Jan 2019.