Phase 1
Completed N=20
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Partial Epilepsy
Source: ClinicalTrials.gov NCT00898560 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Cmax - Maximum Observed Plasma Concentration — 82.4; 75.0; 4170; 4340 pg/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax - Maximum Observed Plasma Concentration |
82.4; 75.0; 4170; 4340 | — |
| 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 |
0.665; 0.453; 37.4; 32.0 | — |
| SECONDARY AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity |
0.768; 0.533; 52.1; 43.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00898560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.