Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by
simvastation acid) in healthy subjects.
To assess the safety of single doses of simvastation administered with and without PEX168
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics
of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration
of each subject's participation in the study was approximately 10 weeks, which included up
to a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week
Follow-up Period.
Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of
China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1
followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a
second single 40-mg oral dose of simvastatin on Day 33.
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