Status:
COMPLETED
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
Lead Sponsor:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01443208
Start Date
November 1 2011
End Date
December 1 2011
Last Update
January 2 2012
Active Locations (1)
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1
Pfizer Investigational Site
Seoul, South Korea, 110-744