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Paxil Table

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648193Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mgEARLY_PHASE1 COMPLETED 36Dec 1, 2006Jan 1, 2007Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALParoxetine hydrochloride 40 mg tablet
2ACTIVE_COMPARATORPaxil® 40 mg Table
Interventions
NameTypeDescription
Paroxetine hydrochloride 40 mg tabletDRUG40mg, single dose fasting
Paxil® 40 mg TableDRUG40mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or female of non-childbearing potential. 1. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: 1. postmenopausal with an absence of menses for a...

Countries:United States
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