Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- Cmax (CBZ) - the Maximum Plasma Concentration
研究概览
简要总结
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.
详细描述
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18 to 45 years inclusive;
- •Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
- •Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at screening;
- •Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
- •Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
- •Non-smokers or ex-smokers;
- •Able and willing to give written informed consent;
- •If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
- •If female, had a negative urine pregnancy test at screening and admission to each treatment period.
排除标准
- •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; have a clinically relevant surgical history;
- •History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives [e.g., carbamazepine, oxcarbazepine] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);
- •Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;
- •History of alcoholism or drug abuse;
- •Consumed more than 14 units1 of alcohol a week;
- •Significant infection or known inflammatory process on screening or admission to each treatment period;
- •Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
- •Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion;
- •Had donated or received any blood or blood products within the 3 months prior to screening;
- •Vegetarians, vegans or have other medical dietary restrictions;
- •Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;
- •Unwilling or unable to give written informed consent;
- •If female, was pregnant or breast-feeding;
- •If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;
- •Had received an investigational drug within 3 months of screening or was currently participating in another study.
研究组 & 干预措施
Group A
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
干预措施: BIA 2-093 (Drug)
Group A
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
干预措施: Carbamazepine (Drug)
Group B
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
干预措施: BIA 2-093 (Drug)
Group B
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Cmax (CBZ) - the Maximum Plasma Concentration
时间窗: Day 28 to 35
Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ
时间窗: Day 28 to 35
Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE
时间窗: Day 28 to 35
Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg CBZE - carbamazepine-epoxide is the active metabolite of CBZ
Cmax (BIA 2-093) - the Maximum Plasma Concentration
时间窗: Day 7 to 35
Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Cmax (CBZE) - the Maximum Plasma Concentration
时间窗: Day 28 to 35
Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily CBZE - carbamazepine-epoxide is the active metabolite of CBZ
AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093
时间窗: Day 7 to 35
Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
次要结局
未报告次要终点