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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Single dose sertraline 100 mg, tablet and solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC) | 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. | 72 hour intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability comparison between sertraline tablet and sertraline liquid | 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine J Steffen, Pharm.D., Ph.D. | Neuropsychiatric Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Institute | Fargo | North Dakota | 58103 | United States |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Body Composition and Weight |
Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory. |
| 72 hours |
| Hepatic Function | To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time. | 72 hours |
| Plasma Protein Concentrations | To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels. | 72 hours |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |