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Alprazolam

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

Alprazolam · 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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