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The sustained-release capsule of urapidil (BKU), a new antihypertensive currently on the West German market as Ebrantil<SUP>®</SUP>, was studied in a phase 1 trial with doses ranging 15-90mg (1/ (2-3) times the German dosage), and the results obtained were as follows:<BR>1. Orthostatic disorders, side effects on the central nervous system and vasodilative symptoms and gastrointestinal disorders were found dose-dependently. These mild symptoms were occurred mostly 4 hr after administration in related with the plasma levels and thereafter disappeared.<BR>2. Blood pressure was lowered at the dose of 60mg in the standing position and 90mg in supine, sitting and standing position. No other drug-related changes were observed in heart rate, electrocardiogram and laboratory findings.<BR>3. In pharmacokinetic studies, the present results were in agreement with thoseobtained with German volunteers, and detectable racial differences were not observed. In a total of 18 cases, T<SUB>1/2</SUB> and maximum plasma concentration time (T<SUB>max</SUB>) were 3.2±0.3hr (mean± S.E.) and 3.8±0.2hr, respectively. Maximum plasma concentration (C<SUB>max</SUB>) and AUC were dose-dependent. Recoveries in 24 hrurine were11.8±1.8% to 18.3±3.1% for the unchanged, 20.8±4.3% to 30.8±1.8% for hydroxylated metabolite and 2.2±0.4% to 2.9±0.6% for N-demethylated metabolite.
- 一般社団法人 日本臨床薬理学会の論文
一般社団法人 日本臨床薬理学会 | 論文
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