CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Tamoxifen +1 moredrug
Likely dose
Tamoxifen 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01189500
NCT01189500Phase 4Completed
CompareCT.gov

An Open-Label, 2-Period Sequential Drug Interaction Study To Evaluate The Effect Of A 100 Mg Dose Of Desvenlafaxine SR On The Pharmacokinetics Of Tamoxifen When Co-Administered In Healthy Post-Menopausal Female Subjects

Pfizer·interventional·Posted Aug 26, 2010·Updated Nov 7, 2011

In Brief

A Phase 4 clinical trial evaluating Tamoxifen and Tamoxifen and Desvenlafaxine Succinate Sustained Release for Pharmacokinetics. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.8 years ago

Interventions

Tamoxifendrug

Period 1-Tamoxifen 40mg on study day 1.

Tamoxifen and Desvenlafaxine Succinate Sustained Releasedrug

Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.