Status:
COMPLETED
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Pharmacokinetics
Cytochrome P-450 CYP2D6
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01188668
Start Date
August 1 2010
End Date
October 1 2010
Last Update
November 7 2011
Active Locations (2)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33126
2
Pfizer Investigational Site
Miami, Florida, United States, 33134