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Nicorette Strongmint lozenge

Phase 1

Tobacco Dependence | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jul 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment244

FDA Designations

No designations recorded

Clinical trial landscape

Nicorette Strongmint lozenge · 1 trial · 1 indication

Phase 1 1
NCT03130179A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.Tobacco Dependence
COMPLETED244 Analytics
PHASE1COMPLETED
A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.
Tobacco Dependence
NCT03130179244
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Study Endpoints

Primary Endpoints

Peak Plasma Concentration (Cmax) of nicotine
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.

The maximum observed plasma concentration (Cmax)

The time at which the maximum nicotine concentration (Cmax) occurs (Tmax)
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.

Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs

Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.

AUCt is defines 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
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug 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).

The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.
Extrapolation from 12 hours after start of drug administration until infinity.

The area under the plasma concentration versus time curves from start of drug administration until infinity.

Determination of the terminal elimination rate constant (lambda_z) for nicotine.
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.

The rate at which the drug is removed from the body system.

The plasma half-life (t1/2) of nicotine.
At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.

The time taken for the nicotine plasma concentration to fall to half its original value.

Secondary Endpoints

Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg.
From first dose received up to 3.5 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 Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg - By Worst-Case Severity.
From first dose received up to 3.5 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 Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg.
From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Nicorette Strongmint lozenge 4mgEXPERIMENTALA single dose of one nicotine 4 mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa.
Niquitin Minimint lozenge 4mgACTIVE_COMPARATORA single dose of one nicotine 4mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa.

Interventions

NameTypeDescription
Nicorette Strongmint lozenge 4 mgDRUGA single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.
Niquitin MiniMint lozenge 4 mgDRUGA single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and/or female subjects 18 to 45 years of age, inclusive, and being verified "Healthy". ("Healthy" is defined as absence of any diseases or abnormalities on the basis of physical examination, standard clinical laboratory and instrumental examinations performed at the scre...

Countries:Russia
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Frequently asked questions about Nicorette Strongmint lozenge

What is Nicorette Strongmint lozenge used for?

Nicorette Strongmint lozenge is used for tobacco dependence, specifically to help adult smokers who are motivated to quit. It is a small molecule nicotine replacement therapy being developed by Johnson & Johnson. The drug is currently in Phase 1 clinical development and is considered investigational.

Who makes Nicorette Strongmint lozenge?

Nicorette Strongmint lozenge is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is being studied for the treatment of tobacco dependence and is currently in Phase 1 clinical trials.

What phase is Nicorette Strongmint lozenge in?

Nicorette Strongmint lozenge is in Phase 1 clinical development. It is an investigational drug for tobacco dependence and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Nicorette Strongmint lozenge in?

Nicorette Strongmint lozenge has one completed clinical trial registered as NCT03130179, titled 'A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.' This Phase 1 study enrolled 244 participants in Russia and was an active-controlled, randomized trial.

Is Nicorette Strongmint lozenge the same as other nicotine replacement therapies?

Nicorette Strongmint lozenge is a nicotine replacement therapy being compared to another nicotine replacement product in a bioequivalence study. The trial NCT03130179 was designed to assess whether the two therapies are equivalent in healthy adult smokers motivated to quit smoking.