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Nicorette Extra Mint Gum

Phase 1

Tobacco Dependence | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 3, 2019

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 Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03259607Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy SmokersPHASE1 COMPLETED 76 — — Aug 14, 2017Jan 9, 2018Jan 3, 20191 China
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Study Endpoints
Primary Endpoints
Peak Plasma Concentration (Cmax) of nicotine.
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.
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.
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).

Secondary Endpoints
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 48 hours.
The time at which the maximum nicotine concentration (Cmax) occurs (Tmax).
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.
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.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALNicorette Extra Mint 2 mg Gum
Treatment BACTIVE_COMPARATORNicorette Mint 2 mg Gum
Treatment CEXPERIMENTALNicorette Extra Mint 4 mg Gum
Treatment DACTIVE_COMPARATORNicorette Mint 4 mg Gum
Interventions
NameTypeDescription
Nicorette Extra Mint 2 mg GumDRUGA 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 GumDRUGA 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 GumDRUGA 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 GumDRUGA single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. 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 examinati...

Countries:China
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