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AED/Statin Interaction Study

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug); atorvastatin (Drug); phenytoin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

Official title: An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Steady-state Cmax and AUC (0-t) of atorvastatin

Secondary outcome: To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Key Inclusion Criteria:

- Body weight >50kg (men) or >45kg (women) and BMI within the range 19-32 kg/m2


- No clinically significant abnormality on clinical examination

Key Exclusion Criteria:

- History or evidence of drug or alcohol abuse or active tobacco use.

- Women of childbearing potential

- Use of prescribed or non-prescribed medications during and within 14 days of starting

study medication.

Locations and Contacts

GSK Investigational Site, Buffalo, New York 14202, United States
Additional Information

Starting date: February 2008
Last updated: May 31, 2012

Page last updated: August 23, 2015

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