AED/Statin Interaction Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00627575

Enrollment

119

Registered

2008-03-03

Start date

2008-02-04

Completion date

2008-09-12

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

drug interaction, pharmacokinetics, healthy volunteers

Brief summary

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.

Interventions

DRUGlamotrigine

Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.

DRUGatorvastatin

Atorvastatin will available as 40 mg tablets.

DRUGphenytoin

Phenytoin will available as 100 mg capsules.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Body weight \>50kg (men) or \>45kg (women) and BMI within the range 19-32 kg/m2 inclusive. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Steady-state Cmax and AUC (0-t) of atorvastatin	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.

Secondary

Measure	Time frame	Description
To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026