NCT02288312已完成1 期
Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers
Bial - Portela C S.A.0 个研究点目标入组 18 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Cmax (BIA 2-005)
研究概览
简要总结
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.
详细描述
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged between 18 and 55 years, inclusive.
- •Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
- •Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
- •Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
- •Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
- •Subjects who had a negative screen for alcohol and drugs of abuse at screening.
- •Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
- •Subjects who were able and willing to give written informed consent.
- •(If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
- •(If female) She had a negative urine pregnancy test at screening and admission to each treatment period.
排除标准
- •Subjects who did not conform to the above inclusion criteria, or
- •Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- •Subjects who had a clinically relevant surgical history.
- •Subjects who had a clinically relevant family history.
- •Subjects who had a history of relevant drug hypersensitivity.
- •Subjects who had a history of alcoholism or drug abuse.
- •Subjects who consumed more than 14 units of alcohol a week.
- •Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
- •Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
- •Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
- •Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
- •Subjects who were vegetarians, vegans or have medical dietary restrictions.
- •Subjects who could not communicate reliably with the investigator.
- •Subjects who were unlikely to co-operate with the requirements of the study.
- •Subjects who were unwilling or unable to give written informed consent.
- •(If female) She was pregnant or breast-feeding.
- •(If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.
研究组 & 干预措施
BIA 2-093 800 mg fasting
Experimental
Tablets 800 mg. Administration:Oral.
干预措施: BIA 2-093 (Drug)
BIA 2-093 800 mg fed
Experimental
Tablets 800 mg. Administration:Oral.
干预措施: BIA 2-093 (Drug)
BIA 2-093 400 mg
Experimental
Tablets 2 x 400 mg. Administration:Oral.
干预措施: BIA 2-093 (Drug)
结局指标
主要结局
Cmax (BIA 2-005)
时间窗: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.
Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)
次要结局
- AUC0-t (BIA 2-005)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.)
- Tmax (BIA 2-005)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.)
- AUC0-∞ (BIA 2-005)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.)
研究者
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