Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Herceptin in Healthy Japanese Male Adults

Meiji Seika Pharma Co., Ltd.0 个研究点目标入组 70 人开始时间: 2014年3月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Healthy Japanese male adults
•2) Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 at the time of screening
•BMI = Body Weight (kg)/[Height (m)]2
•3) The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.

•1) History of hypersensitivity to components of Herceptin or Polaramine or any other drug
•2) Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for Polaramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
•3) History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
•4) History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia

发起方