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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00898560
First received: May 11, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Partial Epilepsy
Drug: eslicarbazepine acetate and Microginon®
Drug: Microginon®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • 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). [ Time Frame: 15-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the tolerability of concomitant administration of ESL 800 mg QD and a combined oral contraceptive. [ Time Frame: 15-day ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Microginon®
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Drug: Microginon®
Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
Active Comparator: ESL 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.
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

Other Names:
  • ESL
  • BIA 2-093

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898560

Locations
Portugal
Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado
Porto, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Manuel Vaz-da-Silva Bial Portela
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00898560     History of Changes
Other Study ID Numbers: BIA-2093-128
Study First Received: May 11, 2009
Last Updated: June 18, 2012
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Partial
Epilepsy
Eslicarbazepine acetate
Combined oral contraceptive
Pharmacokinetics
Tolerability

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Eslicarbazepine acetate
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014