Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01443208
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : January 2, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: desvenlafaxine Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. For single dose: maximum concentration (Cmax) [ Time Frame: day 1 ]
  2. For single dose: time to first occurence of Cmax (Tmax) [ Time Frame: day 1 ]
  3. For single dose: area under curve (0-time for last quantifiable concentration) (AUClast) [ Time Frame: day 1 ]
  4. For multiple dose: maximum concentration (Cmax) [ Time Frame: day 8 ]
  5. For multiple dose: time to first occurence of Cmax (Tmax) [ Time Frame: day 8 ]
  6. For multiple dose: trough concentration (Ctrough) [ Time Frame: day 8 ]
  7. For multiple dose: area under curve (0-24hours) (AUC0-24) [ Time Frame: day 8 ]

Secondary Outcome Measures :
  1. For single dose if data permit: terminal elimination half life (t1/2) [ Time Frame: day 1 ]
  2. For single dose if data permit: area under curve (0-infinity) (AUCinf) [ Time Frame: day 1 ]
  3. For single dose if data permit: oral clearance (CL/F) [ Time Frame: day 1 ]
  4. For single dose if data permit: apparent volume of distribution (Vz/F) [ Time Frame: day 1 ]
  5. For multiple dose if data permit: accumulation factor (Rac) [ Time Frame: day 8 ]
  6. For multiple dose if data permit: terminal elimination half life (t1/2) [ Time Frame: day 8 ]
  7. For multiple dose if data permit: oral clearance (CL/F) [ Time Frame: day 8 ]
  8. For multiple dose if data permit: apparent volume of distribution (Vz/F) [ Time Frame: day 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443208


Locations
Layout table for location information
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01443208     History of Changes
Other Study ID Numbers: B2061137
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011
Keywords provided by Pfizer:
pharmacokinetics
safety
desvenlafaxine
Korean healthy subjects
Additional relevant MeSH terms:
Layout table for MeSH terms
Desvenlafaxine Succinate
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs