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Zyprexa

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 Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Zyprexa · 2 trials · 1 indication

Phase 1 2
NCT00647777Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mgHealthy
COMPLETED32 Analytics
NCT00648921Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mgHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 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
1EXPERIMENTALOlanzapine Tablets 5 mg
2ACTIVE_COMPARATORZyprexa® Tablets 5 mg

Interventions

NameTypeDescription
Olanzapine Tablets 5 mgDRUG5mg, single dose fed
Zyprexa® Tablets 5 mgDRUG5mg, 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 non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration....

Countries:United States
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Frequently asked questions about Zyprexa

What is Zyprexa used for?

Zyprexa is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating its pharmacokinetics. The drug is being developed by Viatris Inc. (NASDAQ: VTRS).

What does Zyprexa target?

The molecular target of Zyprexa has not been disclosed. The drug is a small molecule in Phase 1 development for healthy volunteers, with studies focused on food and fasting effects on its absorption. No specific biological target has been publicly identified.

Who makes Zyprexa?

Zyprexa is being developed by Viatris Inc., a global healthcare company traded on NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy subjects.

What phase is Zyprexa in?

Zyprexa is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Zyprexa in?

Zyprexa has two completed Phase 1 trials: NCT00647777, a food study of olanzapine tablets 5 mg and Zyprexa tablets 5 mg with 32 participants, and NCT00648921, a fasting study with 30 participants. Both were conducted in the United States with healthy adults aged 18 and older.

Is Zyprexa the same as olanzapine?

Zyprexa is being studied as a branded reference product in trials comparing it to generic olanzapine tablets. The trials NCT00647777 and NCT00648921 evaluate the bioequivalence of olanzapine 5 mg tablets versus Zyprexa 5 mg tablets under fed and fasting conditions.