A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- desvenlafaxine
- Conditions
- Major Depressive Disorder
- Sponsor
- Pfizer
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- For multiple dose: trough concentration (Ctrough)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Investigators
Eligibility Criteria
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
Arms & Interventions
100 mg
Intervention: desvenlafaxine
50 mg
Intervention: desvenlafaxine
200 mg
Intervention: desvenlafaxine
Outcomes
Primary Outcomes
For multiple dose: trough concentration (Ctrough)
Time Frame: day 8
For single dose: time to first occurence of Cmax (Tmax)
Time Frame: day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
Time Frame: day 1
For multiple dose: area under curve (0-24hours) (AUC0-24)
Time Frame: day 8
For multiple dose: maximum concentration (Cmax)
Time Frame: day 8
For single dose: maximum concentration (Cmax)
Time Frame: day 1
For multiple dose: time to first occurence of Cmax (Tmax)
Time Frame: day 8
Secondary Outcomes
- For multiple dose if data permit: accumulation factor (Rac)(day 8)
- For multiple dose if data permit: terminal elimination half life (t1/2)(day 8)
- For multiple dose if data permit: apparent volume of distribution (Vz/F)(day 8)
- For single dose if data permit: terminal elimination half life (t1/2)(day 1)
- For single dose if data permit: apparent volume of distribution (Vz/F)(day 1)
- For single dose if data permit: oral clearance (CL/F)(day 1)
- For multiple dose if data permit: oral clearance (CL/F)(day 8)
- For single dose if data permit: area under curve (0-infinity) (AUCinf)(day 1)