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Paroxetine Controlled-Release

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Paroxetine Controlled-Release · 2 trials · 1 indication

Phase 1 2
NCT00647881Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mgHealthy
COMPLETED75 Analytics
NCT00648427Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mgHealthy
COMPLETED75 Analytics
PHASE1COMPLETED
Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALParoxetine Hydrochloride Controlled-Release Tablets 25 mg
2ACTIVE_COMPARATORPaxil CR™ Tablets 25 mg

Interventions

NameTypeDescription
Paroxetine Hydrochloride Controlled-Release Tablets 25 mgDRUG25mg, single dose fed
Paxil CR™ Tablets 25 mgDRUG25mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administ...

Countries:United States
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