drugset / Trial / NCT01235338

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers

NCT01235338

Phase 1 Completed 80 enrolled Shire
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.

Timeline

Start
2010-10-28
Primary completion
2010-12-30
Completion
2011-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Other / unclassified 70 mg
Subject Venlafaxine Small molecule 225 mg

Indications

No indication recorded.