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| ID | Type | Description | Link |
|---|---|---|---|
| EPSCOR | Other Identifier | North Dakota State University |
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| Name | Class |
|---|---|
| Neuropsychiatric Research Institute, Fargo, North Dakota | OTHER |
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This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| venlafaxine | Experimental | Venlafaxine IR and XR, single dosages of each separated by a wash-out period |
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| Venlafaxine XR and Venlafaxine IR | Other | Each participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine IR and Venlafaxine XR | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC) | The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window. | 24 hours intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK Characteristics (Composite) | We will also evaluate other PK characteristics associated with venlafaxine, such as Cmax, Tmax, t1/2, and the ratio of venlafaxine to the active metabolite ODV, and others. | 24 hour collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine J Steffen, Pharm.D., Ph.D. | North Dakota State University & 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 |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |