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Benzonatate -

Phase 1

Cough | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 24, 2012

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01690975Benzonatate Dose Tolerance StudyPHASE1 COMPLETED 9 — — Jul 1, 2012Aug 1, 2012Sep 24, 20121 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Plasma Decay Half-Life (t1/2)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Secondary Endpoints
Maximum tolerated dose (MTD): Assessed at end of study
End of study (2 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo Control
BenzonatateEXPERIMENTALBenzonatate Active
Interventions
NameTypeDescription
PlaceboDRUGPlacebo - single dose at start of each treatment period
Benzonatate - 400 mgDRUGBenzonatate - 400 mg single dose
Benzonatate - 600 mgDRUGBenzonatate - 600 mg single dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG,...

Countries:United States
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