Anxiety
Conditions
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
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
| Measure | Time frame |
|---|---|
| Bioequivalence based on AUC and Cmax | 13 days |
Outcome results
None listed