印度临床试验API接口数据_印度临床试验数据查询接口-摩熵数科开放平台

概述
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数据结构及样例
{
  "试验登记号":"CTRI/2010/091/000275",
  "印度官网链接":"https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ4Mw=",
  "登记日期":"2010-03-19", 
  "其他试验登记号":["GKM-001"],
  "试验标题":"A clinical trial to study the safety and effects of new chemical molecule ADV-1002401 in Healthy, Adult Volunteers and Adult Type-II Diabetic Volunteers",
  "正式的科学名称":"A First in Human, Placebo-Controlled, Randomized, Double-Blind, Rising Single Dose Study of ADV-1002401 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy, Adult Volunteers and Adult Type-II Diabetic Volunteers",
  "试验简称":"Phase 01 Study",
  "国家/地区":["India（印度）"],
  "结束日期":"",
  "最近更新日期":"2013-03-07",
  "试验持续时间":"0 years 3 months 0 days",
  "招募状态":"Not yet recruiting（尚未招募）",
  "注册机构":"印度",
  "药品名称":["ADV-1002401",
            "Placebo"],
  "适应症":["Healthy human volunteers and healthy type 2 DM patients"],
  "试验阶段":"Phase 1 Clinical（Ⅰ期）",
  "试验类型":["Interventional（干预性研究）"],
  "干预类型":["Drug（药品）"],
  "试验设计":["Randomized, Parallel Group, Placebo Controlled Trial"],
  "盲法及设盲对象":"Participant, Investigator and Outcome Assessor Blinded", 
  "摘要":["The study will be a single-centre, placebo-controlled, double blind, randomized, sequential, ascending, single-dose in healthy subjects (Part A) and subjects with type 2 Diabetes Mellitus (T2DM) (Part B). Part B will taken up after completion of Part A. The primary outcome is to assess the safety and tolerability of rising single doses of ADV-1002401 in healthy male subjects and T2DM male subjects following oral administration. The secondary outcomes are to assess the single dose oral pharmacokinetics (PK) and pharmacodynamic (PD) effect of ADV-1002401 in healthy male subjects and T2DM male subjects under fasting conditions"],
  "试验方案":[{"干预组别":"Intervention,ADV-1002401","干预措施":"50, 200, 600, 1200 or 2000 mg"},
    {"干预组别":"Comparator Agent,Placebo","干预措施":"50, 200, 600, 1200 or 2000 mg"}],
  "主要疗效":[{"判定指标": "Safety and tolerability: Adverse events, vital signs measurements, electrocardiograms, physical examinations, clinical laboratory tests and continuous ECG monitoring", "时间节点": "Vital signs (sitting blood pressure and radial pulse rate) will be measured before dosing of investigational product (in the morning of the day of dosing) and at 1, 2, 4, 12, 24 and 48 h after dosing"}],
  "次要疗效":[{"判定指标": "Pharmacokinetic and Pharmacdynemic Assessment", "时间节点": "Post-dose blood samples of 2.0 mL each will be drawn at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 h following drug administration"}], 
  "入组人数":"46",
  "年龄范围":"18 Year(s) - 55 Year(s)",
  "性别":"Male",
  "是否接受健康受试者":"是",
  "入选标准":["Part A:",
  "Male subjects aged between 18 and 55 years (including both) with BMI between 18 to 25 kg/m2 (including both) with normal health as determined by personal medical history, clinical examination, 12 lead ECG, X-ray and laboratory examinations within the clinically acceptable normal range.",
  "Part B:",
  "Male diabetics aged between 18 and 60 years (including both) with BMI between 20 to 32 kg/m2 (including both).",
  "Subjects with fasting blood glucose of 125 to 200 mg/dL while on current medication (metformin or sulfonylurea) / Drug naïve T2DM subjects with fasting plasma glucose of 125 to 200 mg/dL.",
  "Subjects with HbA1c greater than or equal to 7.5%, and less than or equal to 10.5%."],
  "排除标准":["Exclusion Criteria:",
  "History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.",
  "History or presence of significant gastric and/or duodenal ulceration",
  "History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour"],
  "首例受试者入组日期":"2025-05-19",
  "申办单位":["SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES"],
  "合作单位":[""],
  "联系人信息":[{"联系人类别":"公众联系人","姓名":"DR SHUBAMOY MONDAL","联系方式":"7800899044;dr.shubhamoy@gmail.com"},
    {"联系人类别":"科学联系人","姓名":"DR SHUBAMOY MONDALL","联系方式":"7800899044;dr.shubhamoy@gmail.com"}],
   "临床试验结果":[{"文献内容":"GKM-001, a liver-directed/pancreas-sparing Glucokinase modulator (GKM), lowers fasting and post-prandial glucose without hypoglycemia in Type 2 Diabetic (T2D) patients Vikram Ramanathan, Nimish Vachharajani, Rakesh Patel, Rashmi Barbhaiya Diabetes, June 2012, Vol. 61, Supplement 1:A76","文献链接":"https://diabetesjournals.org/diabetes/article/61/Supplement_1/A585/14071/Clinical-Diabetes-Therapeutics"}],
 }