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nicotine lozenge

Phase 1

Healthy Volunteer Smokers | Small molecule | Other |GSK plc|Last Updated: Nov 24, 2014

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651352A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine LozengesPHASE1 COMPLETED 32 — — Feb 1, 2008Mar 1, 2008Nov 24, 2014 - —
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Study Endpoints
Primary Endpoints
To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge.
12 hours
Secondary Endpoints
• To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise with the 4mg prototype lozenge to 4mg standard lozenge;
12 hours
• To evaluate the safety of the 2mg and 4mg prototype lozenges.
Study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2 mg nicotine prototypeEXPERIMENTAL2 mg nicotine prototype
2 mg nicotine lozengeACTIVE_COMPARATORmarketed formulation
4 mg nicotine prototypeEXPERIMENTAL4 mg
4 mg nicotine lozengeACTIVE_COMPARATOR4 mg
Interventions
NameTypeDescription
4 mg nicotine lozengeDRUGmarketed formulation
2 mg nicotine lozengeDRUGmarketed formulation
2 mg nicotine prototypeDRUG2 mg
4 mg nicotine prototypeDRUG4 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject is either male or female between 18 - 55 years of age inclusive. * Subject has a BMI within the range 19-27 kg/m². \[BMI = Weight (kg) ÷ Height (m)²\]. * Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinel...

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