Type 2 Diabetes Mellitus Clinical Trial
Official title:
Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)
To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or normal renal function who were administrated subcutaneously single dose PEX168.To evaluate dose adjustment of PEX168 administered in patients with renal insufficiency and provide a scientific basis in patients with renal insufficiency of rational drug use.
This is an open, non-randomized, parallel-group, single-dose study that evaluated the
pharmacokinetics of PEX168 when single dose administered with PEX168 in patients with renal
insufficiency and normal renal function subjects. The total duration of each subject's
participation in the study was approximately 45 days, which included up to a 14-day
Screening Period, a 31-day PK sample collecting Period.
Center: This study was conducted at two sites in the Third Xiangya hospital of Center South
University and Shanghai Changhai Hospital.All subjects receives a single 200μg doses of
PEX168 injected subcutaneously on Day 1.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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