Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

NCT ID: NCT00397176

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-02-28

Brief Summary

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Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.

Detailed Description

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Conditions

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Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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desvenlafaxine succinate sustained release (DVS SR)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, first-generation (born in Japan, living in the US for less than 5 years)
* Japanese female subjects
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3151A2-1200

Identifier Type: -

Identifier Source: org_study_id