A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects
- Registration Number
- NCT02986529
- Lead Sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
- 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.
Exclusion Criteria
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GV-971 150mg/capsule GV-971 900mg, oral GV-971 300mg/capsule GV-971 900mg, oral GV-971 450mg/capsule GV-971 900mg, oral Placebo Placebos Oral
- Primary Outcome Measures
Name Time Method Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve 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 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) 3 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
🇨🇳Shanghai, Shanghai, China