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Zyprexa

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Zyprexa clinical trials

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?

Zyprexa is a small molecule medicine developed by Viatris Inc. (ticker VTRS). It is also known as Zyprexa Tablets 5 mg. The clinical trial program registered for this asset consists of two completed Phase 1 studies conducted in the United States, with a combined enrollment of 62 healthy adult volunteers.

Who makes Zyprexa?

Zyprexa is developed by Viatris Inc., which trades under the ticker VTRS. The company is the sponsor associated with the registered clinical trials of Zyprexa Tablets 5 mg, including the fasting and food-effect Phase 1 studies conducted in the United States.

What phase is Zyprexa in?

Zyprexa is in Phase 1 clinical development. Two Phase 1 trials are registered, both listed as completed, with no active trials currently recorded. The studies were randomized and used an active control design, and they enrolled a total of 62 participants.

What clinical trials is Zyprexa in?

Two completed Phase 1 trials are registered for Zyprexa. NCT00648921 is a fasting study of olanzapine tablets 5 mg and Zyprexa Tablets 5 mg, enrolling 30 participants. NCT00647777 is a food study of the same products, enrolling 32 participants. Both were conducted in the United States in healthy volunteers aged 18 years and older.