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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01443208

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

36.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: desvenlafaxine Drug: desvenlafaxine Drug: desvenlafaxine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

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 Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50 mg	Drug: desvenlafaxine one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
Experimental: 100 mg	Drug: desvenlafaxine one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
Experimental: 200 mg	Drug: desvenlafaxine two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days

Arm

Intervention/Treatment

Experimental: 50 mg

Drug: desvenlafaxine

one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Experimental: 100 mg

Drug: desvenlafaxine

one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Experimental: 200 mg

Drug: desvenlafaxine

two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days

Outcome Measures

Primary Outcome Measures

For single dose: maximum concentration (Cmax) [day 1]
For single dose: time to first occurence of Cmax (Tmax) [day 1]
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast) [day 1]
For multiple dose: maximum concentration (Cmax) [day 8]
For multiple dose: time to first occurence of Cmax (Tmax) [day 8]
For multiple dose: trough concentration (Ctrough) [day 8]
For multiple dose: area under curve (0-24hours) (AUC0-24) [day 8]

Secondary Outcome Measures

For single dose if data permit: terminal elimination half life (t1/2) [day 1]
For single dose if data permit: area under curve (0-infinity) (AUCinf) [day 1]
For single dose if data permit: oral clearance (CL/F) [day 1]
For single dose if data permit: apparent volume of distribution (Vz/F) [day 1]
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: oral clearance (CL/F) [day 8]
For multiple dose if data permit: apparent volume of distribution (Vz/F) [day 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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