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Prozac Pulvules

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

Prozac Pulvules · 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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Frequently asked questions about Prozac Pulvules

What is Prozac Pulvules used for?

Prozac Pulvules is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics. The drug is being developed by Viatris Inc. and is not yet approved for any indication.

Who makes Prozac Pulvules?

Prozac Pulvules is developed by Viatris Inc., a company traded on the NASDAQ under the ticker symbol VTRS. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Prozac Pulvules in?

Prozac Pulvules is in Phase 1 clinical development. It has one completed trial, NCT00649636, which enrolled 32 healthy volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Prozac Pulvules in?

Prozac Pulvules has one completed clinical trial, NCT00649636, titled "Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg." This Phase 1 study enrolled 32 healthy volunteers in the United States and was active-controlled, though not double-blinded.

Is Prozac Pulvules the same as fluoxetine?

Prozac Pulvules is a formulation of fluoxetine, as indicated by the clinical trial comparing fluoxetine capsules 40 mg to Prozac Pulvules 40 mg. The drug is being studied in healthy volunteers and is currently in Phase 1 development by Viatris Inc.