Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: March 12, 2009
Last updated: March 13, 2009
Last verified: March 2009

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.

Condition Intervention Phase
Drug: Bupropion HCI 300 mg Extended-Release Tablets EON
Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence according to US FDA timelines [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2004
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bupropion HCl 300mg Extended Release Tablet
Drug: Bupropion HCI 300 mg Extended-Release Tablets EON
Active Comparator: 2
WELLBUTRIN XL 300mg Tablets
Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline


Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts 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 orc.
  • Treatment for drug or alcohol dependence.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00861939

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: So R Hong, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00861939     History of Changes
Other Study ID Numbers: B032032
Study First Received: March 12, 2009
Last Updated: March 13, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on March 03, 2015