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Nicorette Strongmint lozenge

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment244
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03130179A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.PHASE1 COMPLETED 244 — — Mar 20, 2017Jun 29, 2017Jul 27, 20181 Russia
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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 — 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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