Conditions: Pharmacokinetics
Keywords: Pharmacokinetic safety and tolerability genetic testing CYP 2D6
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Tamoxifen intervention 2: Tamoxifen and Desvenlafaxine Succinate Sustained Release
Intervention descriptions: intervention 1: Period 1-Tamoxifen 40mg on study day 1. intervention 2: Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.

Protocol document: