Pharmacokinetics and tolerability of intravenous infusion of adenosine (SUNY4001) in healthy volunteers.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY(2000)

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摘要
Aims To examine the tolerability and disposition of i.v. adenosine (SUNY4001) in healthy male Japanese volunteers. Methods SUNY4001 was infused i.v. for 6 min at 0 (placebo), 60, 100, 120 and 140 mu g kg(-1) min(-1) in a dose-escalating manner in 30 healthy subjects. Adenosine and its metabolites were determined in the plasma and urine. Results Only plasma hypoxanthine was increased from 3 min during until 5-10 min after SUNY4001 infusion at the higher rates without any significant dose-related changes in plasma adenosine, inosine, xanthine or uric acid, or in urinary adenosine and all metabolites compared with the placebo. There was a dose-related increase in the incidence of subjective symptoms such as heat sensation, flushed face, dyspnoea, chest discomfort, etc. Transient and self-subsiding episodes of second-degree atrioventricular block were found in two subjects each at the higher doses. Conclusions Adenosine infusion at less than or equal to 140 mu g kg(-1) min(-1) was concluded to be generally well tolerated.
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关键词
adenosine,healthy volunteer,metabolite,pharmacokinetics,tolerability
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