Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Miami, Florida 33126


Purpose:

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.


Criteria:

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


NCT ID:

NCT01189500


Primary Contact:

Study Director
Pfizer CT.gov Call Center
Pfizer


Backup Contact:

N/A


Location Contact:

Miami, Florida 33126
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.