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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898560
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Partial Epilepsy Drug: eslicarbazepine acetate and Microginon® Drug: Microginon® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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Arms and Interventions
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Arm Intervention/treatment
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)
Experimental: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898560


Locations
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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
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Principal Investigator: Manuel Vaz-da-Silva Bial Portela
More Information
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00898560    
Other Study ID Numbers: BIA-2093-128
First Posted: May 12, 2009    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Partial
Epilepsy
Eslicarbazepine acetate
 Combined oral contraceptive
Pharmacokinetics
Tolerability
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
 Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action