NCT00901576

A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers

A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SPD503	SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
DRUG	Concerta	CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
DRUG	SPD503 + Concerta	SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Timeline

• Start date: 2009-05-18
• Primary completion: 2009-07-06
• Completion: 2009-07-06
• First posted: 2009-05-14
• Last updated: 2021-06-14
• Results posted: 2010-05-19

Locations

1 site across 1 country: United States