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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 Guanfacine

Area 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

Page last updated: August 23, 2015

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