Clinical pharmacology study to evaluate the drug-drug interactions of TAS-115 in healthy subjects

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 60 人开始时间: 2022年3月7日最近更新: 2024年12月11日

试验速览

暂无简介。

•(1) Provided written informed consent
•(2) Men aged 20 or older and younger than 40 years at the time of consent
•(3) Weigh at least 50.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.5 to < 25.0 kg/m2
•(4) Vital signs obtained in screening tests within the following ranges
•a) Systolic blood pressure (in supine position), 90 to 139 mmHg
•b) Diastolic blood pressure (in supine position), 40 to 89 mmHg
•c) Pulse rate ranging from 40 to 99 beats/min
•d) Body temperature (axilla) ranging from 35.0 to 37.0
•(5) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests

•Accompanying diseases considered inappropriate for participation in this study including hepatic diseases, renal diseases, gastrointestinal diseases, cardiovascular diseases, hematologic diseases, respiratory diseases, immunologic or allergic diseases, neurological or psychiatric diseases, metabolic or endocrinological diseases, or malignant tumors, or a history of these diseases

PK parameters of TAS-115, digoxin, Rosuvastatin, Metformin (Cmax, AUClast, and AUCinf)

发起方