NCT00898560

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	eslicarbazepine acetate and Microginon®	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
DRUG	Microginon®	Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2009-05-12
• Last updated: 2014-12-12
• Results posted: 2014-12-12

Locations

1 site across 1 country: Portugal