Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT01214382|
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Roux en Y Gastric Bypass Surgery||Drug: Sertraline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Single dose sertraline 100 mg, tablet and solution
Other Name: Zoloft
- Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC) [ Time Frame: 72 hour intervals ]The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.
- Bioavailability comparison between sertraline tablet and sertraline liquid [ Time Frame: 72 hours ]To characterize the relative bioavailability of the tablet formulation of sertraline 100mg as compared to a reference dose of the liquid preparation of sertraline 100mg before and at three and 12 months following RYGBP.
- Body Composition and Weight [ Time Frame: 72 hours ]Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory.
- Hepatic Function [ Time Frame: 72 hours ]To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time.
- Plasma Protein Concentrations [ Time Frame: 72 hours ]To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.
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): NCT01214382
|United States, North Dakota|
|Neuropsychiatric Research Institute|
|Fargo, North Dakota, United States, 58103|
|Principal Investigator:||Kristine J Steffen, Pharm.D., Ph.D.||Neuropsychiatric Research Institute|