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Alprazolam

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

Alprazolam · 2 trials · 1 indication

Phase 1 2
NCT00829426Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting ConditionsHealthy
COMPLETED32 Analytics
NCT00830024Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting ConditionsHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
Healthy
NCT0082942632
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PHASE1COMPLETED
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
Healthy
NCT0083002436
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
AlprazolamEXPERIMENTALAlprazolam 3mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
Xanax XR®ACTIVE_COMPARATORXanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg ER Tablet (test) dosed in second period
Alprazolam (test)EXPERIMENTALAlprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period

Interventions

NameTypeDescription
Alprazolam Extended-Release 3 mg TabletsDRUG1 x 3 mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy non-smoking men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. * Screening procedures: Each subject will complete the...

Countries:United States
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