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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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics, Cytochrome P-450 CYP2D6, Human CYP3A4 Protein
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01188668
Pfizer
Completed
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects

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Pfizer Clinical Trials Contact Center

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[email protected]

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1-800-718-1021

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