NCT01536366已完成1 期
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers
Bial - Portela C S.A.1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2009年6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
- 27
- 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 the CYP2C8 inhibition by BIA 9-1067.
详细描述
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give written informed consent.
- •Male or female subjects aged between 18 and 45 years, inclusive.
- •Subjects of body mass index (BMI) between 19 and 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.
- •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 for at least 3 months.
- •(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
- •(If female) She 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.
- •Clinically relevant surgical history.
- •Any abnormality in the coagulation tests.
- •Any abnormality in the liver function tests.
- •A history of relevant atopy or drug hypersensitivity.
- •History of alcoholism or drug abuse.
- •Consumed more than 14 units of alcohol a week.
- •Significant infection or known inflammatory process at 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.
- •Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion.
- •Had previously received BIA 9-
- •Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
- •Had participated in more than 2 clinical trials within the 12 months prior to screening.
- •Had donated or received any blood or blood products within the 3 months prior to screening.
- •Vegetarians, vegans or had medical dietary restrictions.
- •Cannot communicate reliably with the investigator.
- •Unlikely to co-operate with the requirements of the study.
- •Unwilling or unable to gave written informed consent.
- •Employees at BIAL - Portela & Cª, S.A.
- •(If female) She was pregnant or breast-feeding.
- •(If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
研究组 & 干预措施
Group 1
Experimental
Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
干预措施: BIA 9-1067 (Drug)
Group 1
Experimental
Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
干预措施: Repaglinide (Drug)
Group 2
Experimental
Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
干预措施: BIA 9-1067 (Drug)
Group 2
Experimental
Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
干预措施: Repaglinide (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Concentration
时间窗: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.
次要结局
- Tmax - Time of Occurrence of Cmax(pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.)
- AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration(pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.)
- AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity(pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.)
研究者
研究点 (1)
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