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

Phase 1

Completed

• Conditions: Partial Epilepsy
• Interventions: Drug: Microginon®; Drug: eslicarbazepine acetate and Microginon®

• Registration Number: NCT00898560
• Lead Sponsor: Bial - Portela C S.A.

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

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-05
• Results First Submitted QC: 2014-12-05
• Last Update Submitted: 2014-12-05
• Results First Posted: 2014-12-12
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microginon®	Microginon®	A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
ESL and Microginon®	eslicarbazepine acetate and Microginon®	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.

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Plasma Concentration	15-day	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).

Secondary Outcome Measures

Name	Time	Method
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity	15-day	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).
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	15-day	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).

Trial Locations

Locations (1)

Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado; 🇵🇹 Porto, Portugal