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

Primary Purpose

Partial Epilepsy

Status
Completed
Phase
Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
eslicarbazepine acetate and Microginon®
Microginon®
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy focused on measuring Partial, Epilepsy, Eslicarbazepine acetate, Combined oral contraceptive, Pharmacokinetics, Tolerability

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Microginon®

ESL and Microginon®

Arm Description

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

Outcomes

Primary Outcome Measures

Cmax - Maximum Observed Plasma Concentration
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

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

Full Information

First Posted
May 11, 2009
Last Updated
December 5, 2014
Sponsor
Bial - Portela C S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00898560
Brief Title
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
Partial, Epilepsy, Eslicarbazepine acetate, Combined oral contraceptive, Pharmacokinetics, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microginon®
Arm Type
Other
Arm Description
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Arm Title
ESL and Microginon®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
eslicarbazepine acetate and Microginon®
Other Intervention Name(s)
ESL, BIA 2-093
Intervention Description
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
Intervention Name(s)
Microginon®
Intervention Description
Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
Primary Outcome Measure Information:
Title
Cmax - Maximum Observed Plasma Concentration
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Vaz-da-Silva
Organizational Affiliation
Bial Portela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado
City
Porto
ZIP/Postal Code
4745-457
Country
Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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