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We intra-articularly administered high
molecular weight sodium hyaluronate (NRD101)
at a single dose of 15similar50 mg in the
knee in 29 healthy male volunteers and evaluated
its safety and pharmacokinetics.
1) Symptoms such as slight pain during
motion and malaise developed but were
not dose-dependent. Similar symptoms were
also observed with the placebo. Increases
in WBC, GOT and GPT were observed in some
subjects, but these changes were transient
and not dose-dependent. The blood HA concentration
did not increase. No abnormalities associated
with NRD101 were observed, and this drug
was well tolerated.
2) The serum HA concentration changed
in the range of about 30similar150 ng/ml
after administration of NRD101 at each
dose or the placebo. Thus, the serum HA
concentration did not significantly exceed
its physiological range after administration
of exogenous HA into the knee.
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JPT
Online 
