Healthy
Conditions
Brief 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.
Interventions
DRUGdesvenlafaxine succinate SR
desvenlafaxine succinate SR
OTHERPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine | 2 months |
Outcome results
None listed