Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

Vasomotor Symptoms Clinical Trial

Official title:

Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397176
• Other study ID #: 3151A2-1200
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2006
• Last updated: December 19, 2007
• Start date: November 2006
• Est. completion date: February 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy, first-generation (born in Japan, living in the US for less than 5 years)

• Japanese female subjects

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Drug:
• desvenlafaxine succinate sustained release (DVS SR)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, Tolerability, PK