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Xanax

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 Trials3
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Xanax · 3 trials · 1 indication

Phase 1 3
NCT00647894Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mgHealthy
COMPLETED24 Analytics
NCT00647634Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mgHealthy
COMPLETED21 Analytics
NCT00650299Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mgHealthy
COMPLETED21 Analytics
PHASE1COMPLETED
Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 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
1EXPERIMENTALAlprazolam Extended-Release Tablets 1 mg
2ACTIVE_COMPARATORXanax XR Tablets 1 mg

Interventions

NameTypeDescription
Alprazolam Extended-Release Tablets 1 mgDRUG -
Xanax XR Tablets 1 mgDRUG -
Alprazolam Extended-Release Tablets 3 mgDRUG3mg, single dose fasting
Xanax XR® Tablets (3 mgDRUG3mg, single dose fasting
Xanax XR® Tablets 3 mgDRUG3mg, 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/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...

Countries:United States
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Frequently asked questions about Xanax

What is Xanax used for?

Xanax is used for the treatment of anxiety and panic disorders. It is a small molecule drug developed by Viatris Inc. (VTRS). The drug is currently in Phase 1 clinical development, with ongoing studies evaluating its safety and pharmacokinetics in healthy volunteers.

Who makes Xanax?

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

What phase is Xanax in?

Xanax is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trials are designed to assess the drug's safety, tolerability, and pharmacokinetic profile in healthy volunteers.

What clinical trials is Xanax in?

Xanax has completed three Phase 1 clinical trials, all conducted in the United States. These include NCT00647634, NCT00647894, and NCT00650299, which evaluated the fasting and fed pharmacokinetics of alprazolam extended-release tablets compared to Xanax XR tablets in healthy volunteers.

Is Xanax the same as alprazolam?

Xanax is a brand name for alprazolam. The clinical trials for Xanax are studies of alprazolam extended-release tablets, comparing them to the reference product Xanax XR. These studies are conducted in healthy volunteers to assess bioequivalence.