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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
* Day 1-5 LDX 30mg * Day 6-10 LDX 50mg * Day 11-15 LDX 70mg * Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily * Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily * Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily * Day 31-34 Venlafaxine XR 150mg daily * Day 35-38 Venlafaxine XR 75mg daily.
* Day 1-5 Venlafaxine XR 75mg * Day 6-10 Venlafaxine XR 150mg * Day 11-15 Venlafaxine XR 225mg * Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily * Day 21-25 Venlafaxine XR and LDX 50mg daily * Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily * Day 31-34 Venlafaxine XR 150mg * Day 35-38 Venlafaxine XR 75mg.
Clinical Pharmacology of Miami
Miami, Florida, United States
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.
Time frame: Day 15 and Day 30 (24 hour sampling)
Cmax of d-Amphetamine
d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.
Time frame: Day 15 and Day 30 (24 hour sampling)
Cmax of Venlafaxine Hydrochloride
Venlafaxine Hydrochloride is the active ingredient of Effexor XR
Time frame: Day 15 and Day 30 (24 hour sampling)
Cmax of o-Desmethylvenlafaxine
Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.
Time frame: Day 15 and Day 30 (24 hour sampling)
Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of d-Amphetamine
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of Venlafaxine Hydrochloride
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of o-Desmethylvenlafaxine
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Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)
Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of d-Amphetamine
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of Venlafaxine Hydrochloride
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of o-Desmethylvenlafaxine
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)
Systolic Blood Pressure
Time frame: Baseline and up to 39 days
Diastolic Blood Pressure
Time frame: Baseline and up to 39 days
Pulse Rate
Time frame: Baseline and up to 39 days