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

NCT00901576 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-06-14

Study results available
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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

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).

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-18
Primary Completion
2009-07-06
Completion
2009-07-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901576 on ClinicalTrials.gov