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To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions

To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00883155
Enrollment
36
Registered
2009-04-17
Start date
1998-10-31
Completion date
1998-10-31
Last updated
2017-03-29

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

Conditions

Healthy

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
Lead SponsorINDUSTRY

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

MeasureTime frame
Bioequivalence based on AUC and Cmax29 days

Outcome results

None listed

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