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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SPD503 + Concerta; Drug: SPD503; Drug: Concerta

• Registration Number: NCT00901576
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Study Start: 2009-05-18
• Primary Completion: 2009-07-06
• Study Completion: 2009-07-06
• Results First Submitted: 2010-04-16
• Results First Submitted QC: 2010-04-16
• Results First Posted: 2010-05-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Subjects must be normal healthy adult volunteers with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at the screening visit

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPD503 + Concerta	SPD503 + Concerta	-
SPD503	SPD503	-
Concerta	Concerta	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Time of Maximum Plasma Concentration (Tmax) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Time of Plasma Half-Life(T 1/2) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Cmax of d-Methylphenidate	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
AUC of d-Methylphenidate	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Tmax of d-Methylphenidate	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
T 1/2 of d-Methylphenidate	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Trial Locations

Locations (1)

Advanced Biomedical Research, Inc.; 🇺🇸 Hackensack, New Jersey, United States