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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Eslicarbazepine acetate; Ethinyl Estradiol

Criteria

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