Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects

To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

Inclusion Criteria:

• Healthy male and/or female subjects
• Between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

• Elevated risk of suicide, in the opinion of the investigator or expert consultant
• Pregnant or nursing females
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception