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

Phase 1 Completed 38 enrolled Shire

RandomizedCrossoverOpen-labelOther

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.

Timeline

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

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guanfacine	Small molecule	4 mg	Oral
Comparator	Methylphenidate	Small molecule	36 mg	Oral

Indications

No indication recorded.