Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects

Conditions
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Partial Epilepsy

Intervention / Treatment
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* Drug: eslicarbazepine acetate and Microginon®
* Drug: Microginon®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal female subjects Age 18-40 years, inclusive Body mass index (BMI) 19-30 kg/m2, inclusive Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening Negative urine pregnancy test at screening and admission to each treatment period. Using one of the following methods of contraception: double barrier or intrauterine device Exclusion Criteria: Subjects who have any contra-indication to the use of oral contraceptives History or presence of clinically relevant diseases, disorders or surgical history History of alcoholism or drug abuse Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microginon®<br>A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). | Drug: Microginon®<br>* Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)<br>|
| Experimental: ESL and Microginon®<br>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. | Drug: eslicarbazepine acetate and Microginon®<br>* 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<br>* Other names: BIA 2-093;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma Concentration | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | 15-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | 15-day | 
| AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | 15-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial, Epilepsy, Eslicarbazepine acetate, Combined oral contraceptive, Pharmacokinetics, Tolerability