Healthy
Conditions
Keywords
Antidepressant
Brief summary
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.
Interventions
DRUGBupropion HCl 100 mg Tablets (Invamed Inc.)
DRUGWellbutrin 100 mg Tablets (Glaxo Wellcome)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 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 | 29 days |
Outcome results
None listed