Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
|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|
|Primary Completion Date :||August 2014|
|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.
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|