Drug-Drug interaction study of AJM300 (2)- Combination clinical pharmacology study of rifampicin in healthy male subjects

Takeuchi Yutaka0 个研究点目标入组 20 人开始时间: 2023年6月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. A Japanese healthy male adult aged from 20 to less than 46 inclusive at the time of written informed consent
•2. A BMI meeting the following criterion at screening: Japanese subjects, >= 18.5 and < 25.0 kg/m2
•3. Judging by the investigator or sub-investigator to have no significant clinically relevant abnormalities in examination findings, physiological tests, and laboratory tests, and who have no problem participating in this study
•4. Consenting in writing to participate in this clinical study on his own free will and able to comply with the requirements in the clinical study

•1. History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment
•2. Subjects who are contraindicated to administer the rifampicin according to the current label of the drug.
•3. Subjects who have a white blood cell count of 4000/uL or less at screening and on the day of hospitalization (sequence 1 to 4: day -2, sequence 5: day -1)
•4. Subjects who took grapefruit, grapefruit juice and foods containing these ingredients within 8 days before the start of the clinical trial and St. John's wort and their ingredients within 15 days before the start of the clinical trial.
•5. Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator

发起方

Takeuchi Yutaka