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Completed

NCT Number: NCT00898560

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

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).

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Key information

Conditions

Partial Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Porto, 4745-457, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eslicarbazepine acetate and Microginon®

Drug

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

Other names: ESL, BIA 2-093

Microginon®

Drug

Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)

Primary outcomes

  1. Cmax - Maximum Observed Plasma Concentration

    Time frame: 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 outcomes

  1. 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

    Time frame: 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).

  2. AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bial - Portela C S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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