NCT02170649已完成1 期
The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 in Healthy Male Volunteers
Bial - Portela C S.A.0 个研究点目标入组 12 人开始时间: 2001年9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
- 12
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.
详细描述
Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:
- •Male subjects aged between 18 and 45 years, inclusive.
- •Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- •Subjects who were healthy as determined by pre study medical history, physical examination, neurological examination, EEG, and 12-lead ECG.
- •Subjects who had clinical laboratory tests clinically acceptable to the investigator.
- •Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- •Subjects who were negative for alcohol and drugs of abuse at screening and admission.
- •Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
- •Subjects who were able and willing to give written informed consent.
排除标准
- •Subjects who did not conform to the above inclusion criteria.
- •Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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 atopy.
- •Subjects who had a history of relevant drug hypersensitivity.
- •Subjects who had a history of alcoholism or drug abuse.
- •Subjects who consumed more than 21 units of alcohol a week.
- •Subjects who had a significant infection or known inflammatory process on screening and/or admission.
- •Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- •Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- •Subjects who had used prescription drugs within four weeks of first dosing.
- •Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within two months of their first admission to this study.
- •Subjects who had previously received BIA 2-
- •Subjects who had donated and/or received any blood or blood products within the previous two months prior to screening.
- •Subjects who were vegetarians, vegans and/or had 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.
研究组 & 干预措施
Single Group
Experimental
the volunteers received a single 800 mg BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period
干预措施: BIA 2-093 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Maximum observed plasma concentration of BIA 2-093
次要结局
- 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 (AUC0-t)(pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose)
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)(pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose)
- Time of Occurrence of Cmax (Tmax)(pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose)
研究者
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