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

Last updated on December 16, 2017

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
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy post-menopausal female subjects, at least 45 years of age, with confirmed
post-menopausal status

- Hysterectomized subjects

- Body Mass Index (BMI) less than or equal to 34.0 kg/m2

- 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

- Presence or history of deep vein thrombosis or transient ischemic attack

- History of seizure disorder

- Presence or history of glaucoma or increased intraocular pressure

- Allergy to or unable to tolerate tamoxifen, 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

- Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers

NCT01189500
Pfizer
Completed
Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects

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Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female 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 Tamoxifen When Co-Administered In Healthy Post-Menopausal Female Subjects
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pharmacokinetics
  • Drug: Tamoxifen
    Period 1-Tamoxifen 40mg on study day 1.
  • Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release
    Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.
Experimental: Tamoxifen and Desvenlafaxine SR
Interventions:
  • Drug: Tamoxifen
  • Drug: Tamoxifen and 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
30
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status
  • Hysterectomized subjects
  • Body Mass Index (BMI) less than or equal to 34.0 kg/m2
  • 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
  • Presence or history of deep vein thrombosis or transient ischemic attack
  • History of seizure disorder
  • Presence or history of glaucoma or increased intraocular pressure
  • Allergy to or unable to tolerate tamoxifen, 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
  • Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01189500
B2061027
3151A1-1206
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.

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