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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443208
• Other study ID #: B2061137
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2011
• Last updated: December 29, 2011
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• desvenlafaxine
one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
• desvenlafaxine
one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
• desvenlafaxine
two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For single dose: maximum concentration (Cmax)		day 1	No
Primary	For single dose: time to first occurence of Cmax (Tmax)		day 1	No
Primary	For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)		day 1	No
Primary	For multiple dose: maximum concentration (Cmax)		day 8	No
Primary	For multiple dose: time to first occurence of Cmax (Tmax)		day 8	No
Primary	For multiple dose: trough concentration (Ctrough)		day 8	No
Primary	For multiple dose: area under curve (0-24hours) (AUC0-24)		day 8	No
Secondary	For single dose if data permit: terminal elimination half life (t1/2)		day 1	No
Secondary	For single dose if data permit: area under curve (0-infinity) (AUCinf)		day 1	No
Secondary	For single dose if data permit: oral clearance (CL/F)		day 1	No
Secondary	For single dose if data permit: apparent volume of distribution (Vz/F)		day 1	No
Secondary	For multiple dose if data permit: accumulation factor (Rac)		day 8	No
Secondary	For multiple dose if data permit: terminal elimination half life (t1/2)		day 8	No
Secondary	For multiple dose if data permit: oral clearance (CL/F)		day 8	No
Secondary	For multiple dose if data permit: apparent volume of distribution (Vz/F)		day 8	No

External Links

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