AED/Statin Interaction Study
|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|
|Primary Completion Date :||September 12, 2008|
|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.
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|