Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
NCT00397176
Last updated date
ABOUT THIS STUDY
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release
(DVS SR) in healthy Japanese female subjects.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Vasomotor Symptoms
Sex
Female
Age
20-55 years
Inclusion Criteria
Show details
- Healthy, first-generation (born in Japan, living in the US for less than 5 years)
- Japanese female subjects
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women | |||
Official Title ICMJE | Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects | |||
Brief Summary | Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Primary Purpose: Treatment | |||
Condition ICMJE | Vasomotor Symptoms | |||
Intervention ICMJE | Drug: desvenlafaxine succinate sustained release (DVS SR) | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 32 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00397176 | |||
Other Study ID Numbers ICMJE | 3151A2-1200 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |