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Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects

Last updated on March 11, 2019

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Study Location
Clinical Research Institute
Wichita, Kansas, 67211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 men and women aged 18 to 55 years. Healthy as determined by the investigator
on the basis of medical history and physical examination, laboratory test results,
vital signs, and 12-lead electrocardiogram (ECG).

- History of being a nonsmoker for at least 1 year.

- Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1
or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active
enzyme gene alleles) via genetic testing of a blood sample.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence or history of any significant cardiovascular, hepatic, renal, respiratory,
gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
psychiatric disease or any severe conditions of the ears, eyes or throat (such as
glaucoma or increased intraocular pressure).

- Known or suspected alcohol abuse or consumption of more than 2 standard units per day
(a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces
of wine) within the past 6 months.

- Known or suspected current abuse of prohibited drugs or other substances. Use of any
hormonal therapy within 30 days before study day -1 until the end of the partial
inpatient confinement period.

NCT00727064
Pfizer
Completed
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects

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