Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

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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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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desvenlafaxine succinate SR

Group Type EXPERIMENTAL

desvenlafaxine succinate SR

Intervention Type DRUG

desvenlafaxine succinate SR

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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desvenlafaxine succinate SR

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1.
2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
3. Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day.

Exclusion:

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes