SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.