Plasma drug concentrations and clinical observations after single or repeated oral administration of afloqualone in healthy volunteers: A phase I study.

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概要

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• 1. A GC/MS method for quantitative determination of afloqualone in plasma was developed using deuterated afloqualone as internal standard. The method permits deermination of the drug in plasma above 5ng/ml.<BR>2. A tablet containing 20mg of afloqualone was given orally to healthy men to study the time course of plasma drug concentrations. The mean plasma afloqualone concentration reached a peak of 37.9ng/ml at 1.29hr and thereafter declined with ahalf-life of 3.34 hr.<BR>3. When a 20mg tablet was administered t. i. d. to healthy men daily for one week, there were neither abnormal laboratory test values attributable to the drug nor accom panying symptoms except for one subject who expressed a feeling of weakness.<BR>4. The same dosage (20mg t. i. d.) was orally administered to healthy men for 2 successive weeks. The drug concentration in plasma was measured 1 and 24hr after single administration on the 1st, 8th, and 15th days. The drug levels on the 8th and 15th days were not significantly different from those on the 1st, proving that the drug was not accumulated. Neither untoward side-effects nor abnormal laboratory testitems were observed in these subject

• 一般社団法人 日本臨床薬理学会の論文

著者

• Miura Yuji

  Biological Research Laboratory Tanabe Seiyaku Co. Ltd.

• TAKEYAMA SHIGEYUKI

  Biological Research Laboratory, Tanabe Seiyaku Co., Ltd.

• TAKEYAMA Shigeyuki

  Biological Research Laboratory and Organic Chemistry Research Laboratory, Tanabe Seiyaku Co., Ltd.

• KONO Takeo

  Biological Research Laboratory, Tanabe Seiyaku Co., Ltd.

• CHISHIMA Susumu

  Biological Research Laboratory, Tanabe Seiyaku Co., Ltd.

• ARAMI Saburo

  Department of Internal Medicine, Kinki Central Hospital of the Mutual Aid Association of Public School Teachers

• SAKAGUCHI Kihei

  Sakaguchi Clinic (Internal Medicine)

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