Effects of Gastric Bypass on Blood Levels of Duloxetine
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 3/30/2013 |
Start Date: | September 2009 |
Contact: | Joshua C Johnson, BA |
Email: | jjohnson@nrifargo.com |
Phone: | 701-365-4970 |
A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine
between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control
subjects matched for body mass index (BMI), age and gender.
Inclusion Criteria:
- Male or female subjects between the ages of 18 and 60 years.
- Subjects must be of good general health by history and physical exam.
- Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y
procedure), no BMI requirement.
- Ten normal control subjects who have met the inclusion criteria and have not received
bariatric surgery and who are matched to the surgery subjects according to body mass
index, age and sex.
- Women of child bearing potential must be practicing an accepted method of birth
control (barrier method or oral contraceptive) and have a negative pregnancy test at
baseline.
- No contraindications to receiving a single capsule of 60 mg of duloxetine
Exclusion Criteria:
- Allergy to duloxetine or any of its constituents.
- Candidates who are pregnant or nursing
- Candidates currently receiving any antidepressant.
- Candidates that are determined to be poor metabolizers for CYP2D6
- Subjects who smoke or use any nicotine products
- Candidates currently receiving a medication that interacts with duloxetine.
- Candidates experiencing clinically significant, unstable neurological, hepatic, renal
or cardiovascular disease.
- Candidates experiencing or with a history of vomiting or diarrhea associated with
bariatric surgery
- Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for
schizophrenia, schizoaffective disorder, bipolar disorder.
- Candidates who have participated in an investigational drug study in past 30 days.
- Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency
or who have a history of drug/alcohol abuse or dependency.
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