AED/Statin Interaction Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00627575|
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: lamotrigine Drug: atorvastatin Drug: phenytoin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects|
|Actual Study Start Date :||February 4, 2008|
|Actual Primary Completion Date :||September 12, 2008|
|Actual Study Completion Date :||September 12, 2008|
Active Comparator: Lamotrigine
Subjects will receive 40 milligram (mg) of Atrovastatin from Days 1-7, from Days 8-56 subjects will receive Lamotrigine and Subjects will receive 300 mg/day of Lamotrigine and 40 mg/day of atorvastatin each morning on Days 57-77.
Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.Drug: atorvastatin
Atorvastatin will available as 40 mg tablets.
Active Comparator: phenytoin
Subjects will receive 40 mg of Atrovastatin from Days 1-7, from Days 8-28, subjects will receive 4mg/kg/day of phenytoin in the morning and will continue to take 40 mg/day of atorvastatin each morning. Subjects will receive taper dose of phenytoin from Days 29-30.
Atorvastatin will available as 40 mg tablets.Drug: phenytoin
Phenytoin will available as 100 mg capsules.
- 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. ]Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state.
- 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. ]Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627575
|United States, New York|
|GSK Investigational Site|
|Buffalo, New York, United States, 14202|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|