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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Plasma Concentration
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Microginon®
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
干预措施: Microginon® (Drug)
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.
干预措施: eslicarbazepine acetate and Microginon® (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Concentration
时间窗: 15-day
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).
次要结局
- AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity(15-day)
- 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(15-day)