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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00397176
Enrollment
32
Registered
2006-11-08
Start date
2006-11-30
Completion date
2007-02-28
Last updated
2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasomotor Symptoms

Brief summary

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

Interventions

DRUGdesvenlafaxine succinate sustained release (DVS SR)

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy, first-generation (born in Japan, living in the US for less than 5 years) * Japanese female subjects

Design outcomes

Primary

MeasureTime frame
Safety, Tolerability, PK—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026