A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: SPD503 (Drug); VYVANSE (Drug); SPD503 and VYVANSE (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Shire
Summary
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE
(lisdexamfetamine dimesylate) when given alone, and in combination.
Clinical Details
Official title: A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Maximum Plasma Concentration (Cmax) of GuanfacineArea Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine Time of Maximum Plasma Concentration (Tmax) of Guanfacine Time of Plasma Half-Life(T 1/2) of Guanfacine Cmax of d-Amphetamine AUC of d-Amphetamine Tmax of d-Amphetamine T 1/2 of d-Amphetamine
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must be normal healthy adult volunteers (with no significant abnormalities
in medical history, physical exam, vital signs or lab evaluations at screening) in
order to be eligible to participate.
Locations and Contacts
Advanced Biomedical Research, Inc., Hackensack, New Jersey, United States
Additional Information
Starting date: July 2009
Last updated: January 7, 2014
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