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

Condition(s) targeted: Major Depressive Disorder

Intervention: desvenlafaxine (Drug); desvenlafaxine (Drug); desvenlafaxine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Primary outcome:

For single dose: maximum concentration (Cmax)

For single dose: time to first occurence of Cmax (Tmax)

For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)

For multiple dose: maximum concentration (Cmax)

For multiple dose: time to first occurence of Cmax (Tmax)

For multiple dose: trough concentration (Ctrough)

For multiple dose: area under curve (0-24hours) (AUC0-24)

Secondary outcome:

For single dose if data permit: terminal elimination half life (t1/2)

For single dose if data permit: area under curve (0-infinity) (AUCinf)

For single dose if data permit: oral clearance (CL/F)

For single dose if data permit: apparent volume of distribution (Vz/F)

For multiple dose if data permit: accumulation factor (Rac)

For multiple dose if data permit: terminal elimination half life (t1/2)

For multiple dose if data permit: oral clearance (CL/F)

For multiple dose if data permit: apparent volume of distribution (Vz/F)

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: November 2011
Last updated: November 30, 2011