Phase 1
Completed N=38
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT00901576 ↗
Enrolled (actual)
38
Serious AEs
0.9%
Results posted
May 2010
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Guanfacine — 2.6; 2.7 ng/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Guanfacine |
2.6; 2.7 | — |
| PRIMARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine |
96.5; 106.7 | — |
| PRIMARY Time of Maximum Plasma Concentration (Tmax) of Guanfacine |
8.1; 8.7 | — |
| PRIMARY Time of Plasma Half-Life(T 1/2) of Guanfacine |
20.4; 22.7 | — |
| PRIMARY Cmax of d-Methylphenidate |
9.9; 9.5 | — |
| PRIMARY AUC of d-Methylphenidate |
102.8; 100.5 | — |
| PRIMARY Tmax of d-Methylphenidate |
6.9; 7.4 | — |
| PRIMARY T 1/2 of d-Methylphenidate |
3.9; 4.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00901576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.