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Sponsored by: |
Actavis Inc. |
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Information provided by: | Actavis Inc. |
ClinicalTrials.gov Identifier: | NCT00865462 |
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in subjects fed a standard meal.
Condition | Intervention | Phase |
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Healthy |
Drug: Abrika Bupropion 150 mg XL Tablet, single dose Drug: Wellbutrin XL® 150 mg Tablet, single dose |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Normal, Healthy Man Following a Standard Meal |
Enrollment: | 30 |
Study Start Date: | July 2004 |
Study Completion Date: | July 2004 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Abrika Bupropion 150 mg XL Tablet, single dose
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Drug: Abrika Bupropion 150 mg XL Tablet, single dose
A: Experimental Subjects received Abrika formulated products under fed conditions
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B: Active Comparator
Wellbutrin XL® 150 mg Tablet, single dose
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Drug: Wellbutrin XL® 150 mg Tablet, single dose
B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
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Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Normal, Healthy Man Following a Standard Meal
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Actavis Inc ( Zaidoon A. Al-Zubaidy, Senior Director, Biopharmaceutics ) |
Study ID Numbers: | 04-0646-004 |
Study First Received: | March 17, 2009 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00865462 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Bupropion Healthy subjects |
Dopamine Uptake Inhibitors Neurotransmitter Agents Dopamine Malnutrition Bupropion |
Psychotropic Drugs Dopamine Agents Healthy Antidepressive Agents, Second-Generation Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Pharmacologic Actions |
Therapeutic Uses Bupropion Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |