A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT02173886|
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Roux en Y Gastric Bypass||Drug: Bupropion SR and XL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Bupropion SR and XL, single dosages of each separated by a wash-out period
Drug: Bupropion SR and XL
- Bupropion Plasma Concentrations/Area-Under-the-Curve (AUC) [ Time Frame: 48 hours intervals ]The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of bupropion SR (sustained release) and bupropion XL (extended release) in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon bupropion plasma concentrations obtained during the 48 hour sample collection window.
- Secondary PK Characteristics [ Time Frame: 48 hour collection ]We will also evaluate other PK characteristics associated with bupropion, such as Cmax, Tmax, t1/2, and the ratio of bupropion to the active metabolite ODV, and others.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173886
|United States, North Dakota|
|Neuropsychiatric Research Institute|
|Fargo, North Dakota, United States, 58103|