A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc. (Drug); WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s): Shirley A Kennedy, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150
mg SR Tablets under fasting conditions.
Clinical Details
Official title: A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence according to US FDA timelines
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: September 2005
Last updated: March 18, 2009
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