Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Open-Label, Paralleled Study of the Pharmacokinetics of HMS5552 Following a Single Oral Dose in Renal Impaired Subjects and Matched Healthy Volunteers
The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in renal impaired subjects and matched healthy adult subjects.
This is an open-label and paralleled study with single oral dose of HMS5552 given to renal
impaired subjects and body index matched healthy volunteers.
The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in
renal impaired subjects and (gender, age and BMI) matched healthy adult subjects.
The secondary objective is to characterize the safety profiles of HMS5552 in single dose in
renal impaired subjects.
The subjects include ESRD subjects without dialysis (P1 group), severe (P2 group), moderate
(P3 group), mild (P4 group), and healthy subjects (H Group) matched with renal impairment
subjects in gender, age and BMI. The number of subjects in each group was 6-8.
The study is divided into two parts:
- Part 1: ESRD subjects without dialysis and matched healthy subjects (P1 and H groups; n
= 8 for each group);
- Part 2: subjects with severe, moderate and mild renal impairment (P2, P3 and P4 groups;
n = 6-8 in each group).
The study initiates from Part 1. The data will be evaluated at the end of Part 1 as the
medium term. Compared with the matched healthy subjects, if the mean AUC of HMS5552 (either
AUClast or AUCinf) increased by ≥ 100% in ESRD subjects without dialysis, which means Part 2
will need to be conducted. The process of Part 2 is the same as that of Part 1
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