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

Pfizer36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

desvenlafaxineDRUG

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

desvenlafaxineDRUG

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

desvenlafaxineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

For single dose: maximum concentration (Cmax)

Time frame: day 1

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: maximum concentration (Cmax)

Time frame: day 8

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

Time frame: day 8

For multiple dose: trough concentration (Ctrough)

Time frame: day 8

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

Time frame: day 8

Secondary Outcomes

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

Time frame: day 1

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

Time frame: day 1

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

Time frame: day 1

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

Time frame: day 1

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

Data from ClinicalTrials.gov

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