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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: desvenlafaxine succinate SR; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818155

3151A1-197

B2061064 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

desvenlafaxine succinate SR

Experimental group

Description:

desvenlafaxine succinate SR

Treatment:

Drug: desvenlafaxine succinate SR

Placebo

Placebo Comparator group

Treatment:

Other: Placebo