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NCT00440427 Clinical Trial

Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)

Depressive Disorder, Major Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440427
Other study ID # 3151A2-1201
Secondary ID
Status Completed
Phase Phase 1
First received February 23, 2007
Last updated December 3, 2007
Start date February 2007
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

To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility - Men or non-pregnant, non-lactating women

- Body mass index 18 - 30 kg/m2

- Body weight greater than or equal to 60kg

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Desvenlafaxine 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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
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