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

BIAL

Status and phase: Completed; Phase 1

Conditions: Partial Epilepsy

Treatments: Drug: eslicarbazepine acetate and Microginon®; Drug: Microginon®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00898560

BIA-2093-128

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Microginon®

Other group

Description:

A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).

Treatment:

Drug: Microginon®

ESL and Microginon®

Experimental group

Description:

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.

Treatment:

Drug: eslicarbazepine acetate and Microginon®