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Zoloft

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 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 Trials2
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00836667Sertraline Hydrochloride 100 mg Tablets, FedPHASE1 COMPLETED 18Mar 1, 2002Apr 1, 2002Aug 19, 20241 Canada
NCT00836849Sertraline Hydrochloride 100 mg Tablets, FastingPHASE1 COMPLETED 24Mar 1, 2002Apr 1, 2002Aug 19, 20241 Canada
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Study Endpoints
Primary Endpoints
Bioequivalence based on Cmax and AUC
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Zoloft® 100 mg TabletsDRUG1 x 100 mg, single-dose fed
Sertraline hydrochloride 100 mg TabletsDRUG1 x 100 mg, single-dose fed
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months. * Sterile status is defined as hysterectomy, bilate...

Countries:Canada
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