Status:
COMPLETED
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Partial Epilepsy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00898560
Start Date
September 1 2008
End Date
November 1 2008
Last Update
December 12 2014
Active Locations (1)
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1
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