NCT02986529已完成1 期
A Double-blind, Randomized, Three-period, Three-way Crossover Design, Placebo Controlled Single Dose Study to Assess the Bioavailability of Sodium Oligo-mannurarate (GV-971) Capsule 150 mg, 300mg, 450mg in Healthy Chinese Male Subjects
Shanghai Greenvalley Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年11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
- 15
- 试验地点
- 1
- 主要终点
- Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
研究概览
简要总结
To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after administration of single oral doses of 900mg in healthy Male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 male subjects;
- •Age：≥18 and ≤45 on the date signing informed consent
- •Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg；
- •Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.
排除标准
- •A subject will be excluded if the answer to any of the following criteria is "yes":：
- •Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
- •Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination
- •Positive serology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test.
- •Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening
- •Participation in any investigational drug or medical instrument study within 3months prior to screening, participation in 3 and more than 3 drug tests in a recent year;
- •Serious infection, trauma and major surgery within 4weeks prior to screening;
- •Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 4 weeks prior to screening, receiving blood transfusion treatment within 8 weeks prior to screening ;
- •Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening.
- •Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
- •Vegetarian or person with dietary restrictions
- •Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study.
- •With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to ccardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
- •Subjects may be allergic to GV-971 in the opinion of the investigator.
- •Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
研究组 & 干预措施
GV-971 300mg/capsule
Experimental
900mg, oral
干预措施: GV-971 (Drug)
GV-971 150mg/capsule
Active Comparator
900mg, oral
干预措施: GV-971 (Drug)
GV-971 450mg/capsule
Experimental
900mg, oral
干预措施: GV-971 (Drug)
Placebo
Placebo Comparator
Oral
干预措施: Placebos (Drug)
结局指标
主要结局
Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
时间窗: 3 days
AUC0-last-the area under the concentration-time curve from zero to the time of the last measurable concentration; computed using the linear trapezoidal rule
时间窗: 3 days
AUC0-∞-the area under the concentration-time curve from zero to the infinity, computed as AUC0-∞=AUC0-last+Clast/λz (λz is the terminal phase rate constant)
时间窗: 3 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese SubjectsPharmacokineticsSafetyNCT03715114Shanghai Greenvalley Pharmaceutical Co., Ltd.45
已完成
1 期
A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970HealthyNCT04708184Galapagos NV12
暂停
3 期
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's DiseaseAlzheimer DiseaseNCT04520412Green Valley (Shanghai) Pharmaceuticals Co., Ltd.2,046
已完成
1 期
A Study to Assess the Relative Bioavailability of JNJ-42756493 TabletsHealthyNCT02466815Janssen Research & Development, LLC12
已完成
1 期
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS PatientsHIV InfectionsColitisNCT00000768National Institute of Allergy and Infectious Diseases (NIAID)24