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Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818155
First Posted: January 7, 2009
Last Update Posted: January 29, 2013
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.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

Condition Intervention Phase
Healthy Drug: desvenlafaxine succinate SR Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Desvenlafaxine Succinate Sustained Release Administered Orally to Healthy Chinese Subjects.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results. [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine [ Time Frame: 2 months ]

Enrollment: 36
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: desvenlafaxine succinate SR
desvenlafaxine succinate SR
Drug: desvenlafaxine succinate SR
desvenlafaxine succinate SR
Placebo Comparator: Placebo Other: Placebo

  Eligibility

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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  1. Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1.
  2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
  3. Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day.

Exclusion:

  1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  2. History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).
  Contacts and Locations
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): NCT00818155


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00818155     History of Changes
Other Study ID Numbers: 3151A1-197
B2061064 ( Other Identifier: Pfizer )
First Submitted: December 23, 2008
First Posted: January 7, 2009
Last Update Posted: January 29, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Desvenlafaxine Succinate
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