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Fluoxetine

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 Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Fluoxetine · 1 trial · 1 indication

Phase 1 1
NCT00649636Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mgHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 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
1EXPERIMENTALFluoxetine Capsules 40 mg
2ACTIVE_COMPARATORProzac Pulvules 40 mg

Interventions

NameTypeDescription
Fluoxetine Capsules 40 mgDRUG40mg, single dose fasting
Prozac Pulvules 40 mgDRUG40mg, single dose fasting
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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. a. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (b-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the evening p...

Countries:United States
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