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To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg

Bioavailability of Alprazolam Tablets

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00913341
Enrollment
30
Registered
2009-06-04
Start date
1991-11-30
Completion date
1991-11-30
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Brief summary

To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.

Interventions

DRUGAlprazolam Tablets, 1 mg (Geneva Pharmaceuticals)
DRUGAlprazolam Tablets, 1 mg (The Upjohn Company)

Sponsors

Sandoz
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

* Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Bioequivalence based on AUC and Cmax13 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026