AED/Statin Interaction Study
This study has been completed.
Information provided by (Responsible Party):
First received: February 20, 2008
Last updated: May 31, 2012
Last verified: April 2011
This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Steady-state Cmax and AUC (0-t) of atorvastatin [ Time Frame: Pre-dose,0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose. ] [ Designated as safety issue: No ]Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state.
Secondary Outcome Measures:
- To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose. ] [ Designated as safety issue: No ]Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin.
|Study Start Date:||February 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Lamotrigine||
Other Name: lamotrigineDrug: atorvastatin
Other Name: atorvastatin
|Active Comparator: phenytoin||
Other Name: atorvastatinDrug: phenytoin
Other Name: phenytoin
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