Clinical pharmacology of ibopamine. (1). Safety and pharmacological actions after single and multiple oral doses in Japanese healthy subjects.

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概要

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• Clinicopharmacological study of ibopamine, a new dopaminergic agent, was conducted in 11 Japanese healthy male volunteers. The safety and the pharmacological actions of the drug were assessed by single and multiple oral administrations.<BR>In single-dose study, 25, 50, 100 and 200mg of ibopamine were administered to 6 subjects 100mg of ibopamine was administered three times a day for 1 wk to 5 subjects in multiple dose study.<BR>Two subjects dropped out during the multiple-dose study because of the increased serum GPT in one case and decreased platelet count in another case.<BR>The rise of serum GPT seemed due to drug effect. However, the fall of platelet count did not seem due to drug effect because the case was diagnosed by a later examination as having idiopathic thrombopenia.<BR>The serum GPT values increased slightly in 2 other cases (up to 45, 46 KU/ml) but they did not drop out from the study.<BR>ECG examination revealed supraventricular premature contractions in a subject during single-dose study and in another subject during multiple-dose study.<BR>No abnormality was noted in subjective symptoms, body temperature, and body weight in both single- and multiple-dose studies.<BR>Blood pressure and pulse rate did not change significantly in both studies.<BR>ETc, which was assessed by mechanocardiography, showed a tendency to be shortened after single administration of ibopamine.<BR>Serum prolactin decreased after single administration of ibopamine.<BR>Diuretic and natriuretic effects were not evident after ibopamine administration.<BR>Urinary excretion of epinephrine, but not of norepinephrine and dopamine, increased significantly after drug administration. The mechanism of these changes remains to be clarified in future studies.

• 一般社団法人 日本臨床薬理学会の論文

著者

• 海老原 昭夫

  大分医科大学医学部臨床薬理学

• 中島 創

  大分医科大学医学部臨床薬理学

• 中島 創

  大分医科大学臨床薬理学教室

• 都留 正展

  大分医科大学臨床薬理学教室

• 大橋 京一

  自治医科大学臨床薬理学教室

• 藤村 昭夫

  大分医科大学臨床薬理学教室

• 日野 尚子

  大分医科大学臨床薬理学教室

• 杉本 孝一

  大分医科大学臨床薬理学教室

• 熊谷 雄治

  大分医科大学臨床薬理学教室

• 岡 太一

  自治医科大学臨床薬理学教室

• 梶山 博行

  大分医科大学臨床薬理学教室

• 杉本 孝一

  大分医科大学臨床薬理

• 藤村 昭夫

  大分医科大学臨床薬理

• 岡 太一

  自治医科大学臨床薬理

• 日野 尚子

  大分医科大学臨床薬理

• 熊谷 雄治

  大分医科大学臨床薬理

• 都留 正展

  大分医科大学臨床薬理

• 大橋 京一

  自治医科大学臨床薬理

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