A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients

Jiangsu HengRui Medicine Co., Ltd.0 个研究点目标入组 30 人开始时间: 2014年6月最近更新: 2016年6月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Jiangsu HengRui Medicine Co., Ltd.
入组人数: 30
主要终点: The maximum plasma concentration (Cmax) of SP2086 acid

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.

详细描述

This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•with a body mass index(BMI) between 19 and 28 Kg/m2;Weight:≥50Kg(male),≥45kg(female)
•The endogenous creatinine clearance of subjects in groups must meet the standards of Ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;Moderate renal insufficiency: 30 to 59 ml/min;Severe renal insufficiency: 15-29 ml/min;End-stage renal disease: < 15 ml/min.Normal renal function: 90 ml/min or more.
•Had signed the informed consent himself or herself voluntarily.

排除标准

•Cannot tolerate oral medicine.
•Not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases.
•Had the digestive surgery that could affect drug absorption.
•The clinical significance of arrhythmia.
•Acute hepatitis, chronic liver disease; ALT or AST value was 2 times greater than upper normal limit, Total bilirubin value was 1.5 times greater than upper normal limit.
•HBV surface antigen, HCV antibody, or HIV antibody was positive.
•history of drug allergy or allergic constitution or family history of allergy.
•Had Used hormonal contraception within 3 months;
•Had Used DPP - IV inhibitor within 2 weeks;
•Had Used traditional Chinese medicine (Chinese herbs, Chinese patent medicine) within 2 weeks;
•Had Used acid inhibitors within 2 weeks;
•Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
•2 days before the randomization till to the end ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion
•The patient had participated three times or more clinical trial in one year, or one time within 3 months.
•Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
•History of blood donation or participate in blood donation, or by blood transfusion in 3 months prior to screening.
•Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.