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Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects

NCT ID: NCT01188668

Last Updated: 2011-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-10-31

Brief Summary

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The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.

Detailed Description

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Conditions

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Pharmacokinetics Cytochrome P-450 CYP2D6 CYP3A4 Protein, Human

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aripiprazole + Desvenlafaxine SR

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Period 1-Aripiprazole 5mg on study day 1.

Aripiprazole + desvenlafaxine succinate sustained release

Intervention Type DRUG

Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.

Interventions

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Aripiprazole

Period 1-Aripiprazole 5mg on study day 1.

Intervention Type DRUG

Aripiprazole + desvenlafaxine succinate sustained release

Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.

Intervention Type DRUG

Other Intervention Names

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DVS-233; Pristiq

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)
* Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history
* An informed consent document signed and dated by the subject

Exclusion Criteria

* History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease
* History of seizure disorder
* Presence or history of glaucoma or increased intraocular pressure
* Allergy to or unable to tolerate aripiprazole, desvenlafaxine, or venlafaxine
* History of substance abuse within 1 year of study
* A positive urine drug screen
* Treatment with an investigational drug within 30 days
* Consumption of grapefruit or grapefruit related citrus fruits
* 12 lead ECG demonstrating QTc \>450 msec at screening
* Pregnant or nursing females
* Use of prescription or nonprescription drugs and dietary supplements
* History of sensitivity to heparin or heparin induced thrombocytopenia
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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3151A1-1207

Identifier Type: -

Identifier Source: secondary_id

B2061026

Identifier Type: -

Identifier Source: org_study_id