Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary pharmacokinetic parameters (Bioequivalence)
研究概览
简要总结
Methodology:
The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations
详细描述
Objectives:
Primary objective:
Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and Sabril granules for oral administration.
Secondary objective:
- Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of vigabatrin (VGB-ST)
- Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subject, aged between 18 and 50 years inclusive;
- •Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, condoms or abstinence) for the duration of the trial and for 1 month after the last study drug administration; Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
- •Non breast-feeding female and negative pregnancy test at screening baseline;
- •Non-smoker subject or smoker of not more than 5 cigarettes per day;
- •Body Mass Index (BMI) between 18,5 and 25 kg/m2 inclusive;
- •Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
- •Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position
- •Normal ECG recording on a 12-lead ECG at the screening visit
- •Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range could be accepted if judged clinically non relevant by the Investigator;
- •Normal dietary habits;
- •Signing a written informed consent prior to selection;
- •Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
排除标准
- •Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders;
- •Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- •History of abnormal vision (e.g. reduced visual field, retinopathy, etc...);
- •Abnormal visual field recorded during the inclusion period;
- •Evidence of any clinically significant acute or chronic disease;
- •Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position;
- •Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration;
- •General anaesthesia within 3 months before administration;
- •Presence or history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician;
- •Inability to abstain from intensive muscular effort;
- •No possibility of contact in case of emergency;
- •Any drug intake (except paracetamol or contraception) during the last month prior to the first administration;
- •History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
- •Excessive consumption of beverages containing xanthine bases (> 4 cups or glasses / day);
- •Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody (not including HSV), or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
- •Positive results of screening for drugs of abuse;
- •Subject who, in the judgment of the Investigator, was likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- •Exclusion period of a previous study;
- •Administrative or legal supervision;
- •Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study
研究组 & 干预措施
VGB-ST
Name of the compound: Vigabatrin ORPHELIA Pharma (VGB-ST) Pharmaceutical form: Soluble tablet Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 16.92.042 (expiry date: 31.05.2017)
干预措施: VGB-ST (Drug)
Sabril
Name of the compound: Sabril (vigabatrin) Pharmaceutical form: granules (sachet) Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 6810 (expiry date: 31.05.2019)
干预措施: VGB-ST (Drug)
结局指标
主要结局
Primary pharmacokinetic parameters (Bioequivalence)
时间窗: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-t
次要结局
- Secondary pharmacokinetic parameters(day 1 or 2)