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Paroxetine

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 Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Paroxetine · 2 trials · 1 indication

Phase 1 1Early Phase 1 1
NCT00650403Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mgHealthy
COMPLETED66 Analytics
PHASE1COMPLETED
Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
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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 Tablet

Interventions

NameTypeDescription
Paroxetine hydrochloride 40 mg tabletDRUG40mg, single dose fed
Paxil® 40 mg TabletDRUG40mg, single dose fed
Paxil® 40 mg TableDRUG40mg, single dose fasting
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Eligibility Criteria

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

Inclusion Criteria: 1. Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. 2. Subjects who completed the screening process within 21 days prior to Period I dosing. 3. Subjects who were healthy adult men a...

Countries:United States
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