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desvenlafaxine

Phase 3

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 8, 2013

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 Trials2
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00329186Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy SubjectsPHASE3 COMPLETED 14May 1, 2006Jun 1, 2007Feb 8, 20131 United States
NCT00818155Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and FemalesPHASE1 COMPLETED 36Jan 1, 2009Feb 1, 2009Jan 29, 2013 -
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Study Endpoints
Primary Endpoints
The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.
2 months
Secondary Endpoints
Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine
2 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
desvenlafaxine succinate SREXPERIMENTALdesvenlafaxine succinate SR
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
desvenlafaxine SRDRUG -
venlafaxine ERDRUG -
desvenlafaxine succinate SRDRUGdesvenlafaxine succinate SR
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women between 18 to 55 years of age * Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ECG) * Hist...

Countries:United States
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