A Phase 1 interventional study of Bupropion 150 mg Extended-Released Tablet, single dose and Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose in Healthy, sponsored by Actavis Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-16.
Sponsored by Actavis Inc. · Phase 1 and Interventional
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.
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 Sustained Release Tablets in Fasted, Normal, Healthy Men.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Actavis Inc. is the lead sponsor of 94 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bupropion 150 mg Extended-Released Tablet, single dose
Drug: Bupropion 150 mg Extended-Released Tablet, single dose
Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose
Drug: Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose
A: Experimental Subjects received Abrika formulated products under fasting conditions
Also known as: Bupropion
B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
Also known as: Bupropion
Rate and Extend of Absorption
Time frame: 120 hours
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Actavis Inc.