:Phase I Study
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概要
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We carried out a phase I study of zomepirac sodium in healthy Japanese volun-teers and studied the safety and pharmacokinetics of the drug.<BR>The volunteers were divided into 5 groups (A-E) of 3 volunteers each and the following dosages were tested: single doses of 50 mg, 100 mg and 200 mg, a divided daily dose of 450 mg (150mg×3) and finally a 3 day continuous administration test of 300 mg (100mg×3) per day.<BR>Absolutely no abnormality was observed in either subjective or objective symp-toms. No remarkable change was seen in the blood pressure, pulse rate, respiratory rate, body temperature or ECG.<BR>In the blood chemistry tests and urinalysis, no abnormalities were observed except that the BUN and the blood creatinine exhibited a tendency to rise. In regard to blood coagulation factors, no definite tendency was observed.<BR>The peak time of blood concentration for a single dose was between 0.5 to 1.5 hours and for the continuous administration at 2 hours.<BR>Urinary excretion was rapid and the main metabolite, glucuronic acid conjugate was excreted at a rate of approximately 50-60%.<BR>During the continuous administration test no increase was observed in either the blood concentration or the excretion rate.<BR>The above results confirm the safety of zomepirac sodium in healthy Japanese volunteers.
- 一般社団法人 日本臨床薬理学会の論文