Conditions: Partial Epilepsy
Keywords: Partial Epilepsy Eslicarbazepine acetate Combined oral contraceptive Pharmacokinetics Tolerability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).

Detailed description:

Arms:
arm 1: A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). arm 2: 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.

Interventions: intervention 1: eslicarbazepine acetate and Microginon® intervention 2: Microginon®
Intervention descriptions: intervention 1: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.

Microginon®: single oral dose on day 14 of treatment period intervention 2: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)

Protocol document: