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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Desvenlafaxine Succinate

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).