Neuropsychiatric Research Institute
Fargo, North Dakota, 58103, United States
NCT Number: NCT02005107
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Fargo, North Dakota, 58103, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Effexor and Effexor XR
Time frame: 24 hours intervals
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.
Time frame: 24 hour collection
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.
North Dakota State University
Other
A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
Acronym: VLX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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