Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects

Phase 4 Completed 30 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2010-08
Primary completion: 2010-10
Completion: 2010-10

Outcome

Met primary endpoint

paper did not alter tamoxifen AUC(inf), AUC(last), and C(max), as reflected by the ratio of adjusted geometric means PMID 25138680 ↗

Publications

Nichols AI, Lubaczewski S, Liang Y, Matschke K, Braley G, Ramey T. Open-label, 2-period sequential drug interaction study to evaluate the effect of a 100-mg dose of desvenlafaxine on the pharmacokinetics of tamoxifen when coadministered in healthy postmenopausal female subjects. Int J Clin Pharmacol Ther. 2014 Oct;52(10):830-41. doi: 10.5414/CP201958.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desvenlafaxine	Other / unclassified	100 mg	—
Subject	Tamoxifen	Small molecule	40 mg	—

Indications

No indication recorded.