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

NCT00901576 | Completed Phase 1 Results

• 1 other identifier: SPD503-114
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

SPD503

EXPERIMENTAL

Drug: SPD503

Concerta

ACTIVE COMPARATOR

Drug: Concerta

SPD503 + Concerta

ACTIVE COMPARATOR

Drug: SPD503 + Concerta

Interventions

SPD503 DRUG

SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets

Also known as: Intuniv

SPD503

Concerta DRUG

CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.

Concerta

SPD503 + Concerta DRUG

SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

SPD503 + Concerta

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Advanced Biomedical Research, Inc.

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Roesch B, Corcoran M, Haffey M, Stevenson A, Wang P, Purkayastha J, Martin P, Ermer J. Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release. Drugs R D. 2013 Mar;13(1):53-61. doi: 10.1007/s40268-013-0009-5.

  PMID: 23519656 RESULT

Related Links

• FDA recall information
• FDA-approved label

MeSH Terms

Interventions

Guanfacine; Methylphenidate

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 14, 2009
• Study Start: May 18, 2009
• Primary Completion: July 6, 2009
• Study Completion: July 6, 2009
• Last Updated: June 14, 2021
• Results First Posted: May 19, 2010

Record last verified: 2021-06

Locations

US (1)