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Venlafaxine PK Following Bariatric Surgery

NCT02005107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Roux en Y Gastric Bypass
  • Sleeve Gastrectomy

Interventions

DRUG

Venlafaxine IR and Venlafaxine XR

Sponsors & Collaborators

  • Neuropsychiatric Research Institute, Fargo, North Dakota

    collaborator OTHER

  • North Dakota State University

    lead OTHER

Principal Investigators

  • Kristine J Steffen, Pharm.D., Ph.D. · North Dakota State University & Neuropsychiatric Research Institute

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02005107 on ClinicalTrials.gov