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

Partial Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898560
• Other study ID #: BIA-2093-128
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2009
• Last updated: December 5, 2014
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Partial Epilepsy

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	15-day	No
Secondary	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).	15-day	No
Secondary	AUC0-8 - 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).	15-day	No