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

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: desvenlafaxine

• Registration Number: NCT01443208
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-29
• Study Start: 2011-11
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg	desvenlafaxine	-
100 mg	desvenlafaxine	-
200 mg	desvenlafaxine	-

Primary Outcome Measures

Name	Time	Method
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: trough concentration (Ctrough)	day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)	day 8
For multiple dose: maximum concentration (Cmax)	day 8
For single dose: maximum concentration (Cmax)	day 1
For multiple dose: time to first occurence of Cmax (Tmax)	day 8

Secondary Outcome Measures

Name	Time	Method
For multiple dose if data permit: accumulation factor (Rac)	day 8
For single dose if data permit: apparent volume of distribution (Vz/F)	day 1
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: 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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Seoul, Korea, Republic of