Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.
研究概览
简要总结
This clinical trial phase I in healthy volunteers is intended to describe the oral bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and intravenous silybin (AUC iv).
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals men who give their written consent to participate in the study, after having received information about the design, the project objectives, the risks and that at any moment they can refuse their cooperation.
- •Understand the purpose of the study and be available for performing hospital visits and and admissions.
- •Age between 18 and 45 years.
- •Healthy subjects, without any organic or psychological pathology
- •Clinical history and physical examination within normal limits.
- •Lack of clinically relevant abnormalities in blood test (hematology, biochemistry, virology) and urine test
- •Vital signs and electrocardiographic recording in the normal range.
- •Males with childbearing potential partners must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method) from the moment of signing the informed consent until 6 months after the end of their participation in the study.
排除标准
- •Subjects suffering from organic or psychological pathology. Prior to the inclusion of any volunteer it should be considered all security parameters mentioned in the protocol (biochemical markers of kidney damage and / or liver out of the normal range set by the laboratory).
- •Subjects who have received prescription drug treatment in the last 15 days or any medication within 48 hours before receiving study medication.
- •Subjects with a BMI that is not between 18 and
- •Known hypersensitivity to any drug
- •Suspected of drug abuse
- •Consumers of alcohol daily and / or acute alcohol poisoning in the last week.
- •Subjects smoking.
- •Have donated blood in the last three months.
- •Participation in any other investigational drug study in the previous 3 months
- •Not to be able to follow instructions or collaborate during the course of the study.
研究组 & 干预措施
Legalón Sil i.v 350 mg
8 healthy volunteers received 1 vial of 350 mg iv of sylibin lyophilisate for solution for infusion (legalon sil) in two hours (single dose).
干预措施: Legalón SIL (Drug)
Silybin-phosphatidylcholine oral 360 mg
8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally.
干预措施: silybin phosphatidylcholine (Drug)
结局指标
主要结局
Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.
时间窗: 1 Month
Patient will be hospitalized in the clinical trial unit in order to obtain plasma concentrations previous to the administration of the corresponding dose and at the following times post-administration: : 20min, 40min, 1h, 1h20min, 1h40min 2h, 2h30min, 3h, 4h, 6h, 8h and 12h. Two more plasma concentrations will be obtained at 5 min and 10 mins post- administration of the iv dose. These measures will be calculated in order to describe the bioavailability of oral sylibinobtained in the different treatment groups.
Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups.
时间窗: 1 Month
Patient will be hospitalized in the clinical trial unit in order to obtain plasma concentrations previous to the administration of the corresponding dose and at the following times post-administration: : 20min, 40min, 1h, 1h20min, 1h40min 2h, 2h30min, 3h, 4h, 6h, 8h and 12h. Two more plasma concentrations will be obtained at 5 min and 10 mins post- administration of the iv dose. These measures will be calculated in order to describe the bioavailability of oral sylibinobtained in the different treatment groups.
次要结局
- Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups.(1 Month)
- Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups.(1 Month)
- To evaluate the safety (adverse events, laboratory abnormalities) and tolerability(2 Months)
- To estimate the inter and intraindividual coefficient of variation (CV)(1 Month)