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

NCT ID: NCT00898560

Last Updated: 2014-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Partial Epilepsy

Keywords

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Partial Epilepsy Eslicarbazepine acetate Combined oral contraceptive Pharmacokinetics Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microginon®

A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).

Group Type OTHER

Microginon®

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

eslicarbazepine acetate and Microginon®

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Microginon®

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

Intervention Type DRUG

Other Intervention Names

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ESL BIA 2-093

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bial - Portela C S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel Vaz-da-Silva

Role: PRINCIPAL_INVESTIGATOR

Bial Portela

Locations

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

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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BIA-2093-128

Identifier Type: -

Identifier Source: org_study_id