- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440427
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Randomized, Open-Label, Single-Dose Parallel Group Study of the Pharmacokinetic Profile, Safety, and Tolerability of 25- and 50-mg Desvenlafaxine Sustained Release (DVS SR) in Healthy Subjects
To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02135
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Men or non-pregnant, non-lactating women
- Body mass index 18 - 30 kg/m2
- Body weight greater than or equal to 60kg
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
February 23, 2007
First Submitted That Met QC Criteria
February 23, 2007
First Posted (Estimate)
February 27, 2007
Study Record Updates
Last Update Posted (Estimate)
December 5, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Desvenlafaxine Succinate
Other Study ID Numbers
- 3151A2-1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder, Major
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Desvenlafaxine Sustained Release (DVS SR)
-
Wyeth is now a wholly owned subsidiary of PfizerTerminated
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedMenopause | Vasomotor SystemUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedMajor Depressive Disorder
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepression | Major Depressive DisorderUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder, Major Depressive DisorderUnited States
-
PfizerCompleted
-
PfizerCompletedMajor Depressive DisorderUnited States, Japan
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder | Depression | Depressive Disorder, MajorUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted