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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00883155
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.

Condition Intervention Phase
Healthy
Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)
Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 1998
Study Completion Date: October 1998
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bupropion HCl 100 mg Tablets (Invamed Inc.)
Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)
Active Comparator: 2
Wellbutrin 100 mg Tablets (Glaxo Wellcome)
Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883155

Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Jameel Razack, M.D. Pharma Medica Research, Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00883155     History of Changes
Other Study ID Numbers: B-09018 
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antidepressant

Additional relevant MeSH terms:
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016