A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers - A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers

Senju Pharmaceutical Co.,Ltd.0 个研究点目标入组 12 人开始时间: 2018年1月13日最近更新: 2023年10月17日

适应症

试验速览

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•1. Subjects with disease, medical history, physical findings, or laboratory abnormalities affecting evaluation of the study 2. Subjects with a medical history of allergies to drugs or food 3. Subjects with a Body mass index of less than 18.5 or exceeding 25.0 or with a weight of less than 50 kg 4. Subject who had underwent surgery known to affect gastrointestinal absorption of the drug (other than appendectomy and herniation) 5. Subjects with previous medical history or current signs of heart disease 6. Subjects who had participated in other clinical studies and had been dosed with other study drugs within 84 days preceding providing consent 7. Subjects who had used drugs other than the study drug used in this study within 7 days preceding treatment initiation of the study drug 8. Subjects who had taken grapefruit, grapefruit juice, or processed food containing those fruits within 7 days preceding treatment initiation of the study drug 9. Subjects who had taken dietary supplement products containing St. John's Wort within 14 days preceding treatment initiation of the study drug 10. (Only for multiple-dose part) Subjects who had shown any abnormal finding at ophthalmic examinations or who had severe myopia.

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