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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DVS/VEN

Group Type ACTIVE_COMPARATOR

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Type DRUG

Venlafaxine Extended Release (VEN ER)

Intervention Type DRUG

VEN/DVS

Group Type ACTIVE_COMPARATOR

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Type DRUG

Venlafaxine Extended Release (VEN ER)

Intervention Type DRUG

Interventions

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Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Type DRUG

Venlafaxine Extended Release (VEN ER)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes