Effects of Gastric Bypass on Blood Levels of Duloxetine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bariatric Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Active drug

All subjects received drug. Single arm.

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

Single dose of 60 mg of duloxetine

Interventions

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Duloxetine

Single dose of 60 mg of duloxetine

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes