Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 major-depressive-disorder
Started Nov 2011
Shorter than P25 for phase_1 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 2, 2012
December 1, 2011
1 month
September 23, 2011
December 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
50 mg
EXPERIMENTAL100 mg
EXPERIMENTAL200 mg
EXPERIMENTALInterventions
one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Seoul, 110-744, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 29, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 2, 2012
Record last verified: 2011-12