A Phase 1 interventional study of Nicorette Extra Mint 2 mg Gum and Nicorette Mint 2 mg Gum in Tobacco Dependence, sponsored by McNeil AB. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by McNeil AB (formerly part of Johnson & Johnson) · Phase 1, Interventional, and Other
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.
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.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 76 is below the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →McNeil AB is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
First submitted before McNeil AB left Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nicorette Extra Mint 2 mg Gum
Drug: Nicorette Extra Mint 2 mg Gum
Nicorette Mint 2 mg Gum
Drug: Nicorette Mint 2 mg Gum
Nicorette Extra Mint 4 mg Gum
Drug: Nicorette Extra Mint 4mg Gum
Nicorette Mint 4 mg Gum
Drug: Nicorette Mint 4 mg Gum
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Peak Plasma Concentration (Cmax) of nicotine.
The maximum observed plasma concentration (Cmax).
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.
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.
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.
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).
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 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).
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).
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs.
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.
The rate at which the drug is removed from the body system.
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.
The time taken for the nicotine plasma concentration to fall to half its original value.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Percentage (%) of subjects experiencing treatment-emergent adverse events by treatment, system organ class, preferred term and 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.
Percentage (%) of subjects with commonly reported treatment-emergent adverse events by system organ class and preferred term.
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.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class and preferred term.
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.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class, preferred term and 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).
Percentage (%) of subjects experiencing treatment-emergent serious adverse events.
Time frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion.
Plan to share: No
Ran from Aug 2017 to primary completion in Dec 2017, 4 months.
Of 46 phase 1 interventional studies under Tobacco Use Disorder, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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