You are here

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 May 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Pharmacokinetics, Open Label, CAZ-AVI, CXL, Effect on Intestinal Flora, Safety
NCT01789528
All Genders
18+
Years
Stockholm,
Hyperlipoproteinemia Type III
NCT00145431
All Genders
18+
Years
Multiple Sites
Hypertriglyceridemia, Hyperlipoproteinemia Type IV
NCT00134498
All Genders
18+
Years
Multiple Sites
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
An Open-Label, 2-Period Sequential Drug Interaction Study To Evaluate The Effect Of A 100 Mg Dose Of Desvenlafaxine SR On The Pharmacokinetics Of Aripiprazole When Coadministered In Healthy Subjects
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Pharmacokinetics
  • Cytochrome P-450 CYP2D6
  • CYP3A4 Protein, Human
  • Drug: Aripiprazole
    Period 1-Aripiprazole 5mg on study day 1.
    Other Name: DVS-233; Pristiq
  • Drug: Aripiprazole + desvenlafaxine succinate sustained release
    Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.
Experimental: Aripiprazole + Desvenlafaxine SR
Interventions:
  • Drug: Aripiprazole
  • Drug: Aripiprazole + desvenlafaxine succinate sustained release
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01188668
B2061026
3151A1-1207
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now