A double-blind, comparator-controlled, randomised, three-period crossover euglycemic clamp trial to evaluate pharmacokinetics of single doses of BC222 insulin lispro in healthy Japanese subjects

Adocia0 个研究点开始时间: 2015年12月7日最近更新: 2016年1月11日

适应症

试验速览

暂无简介。

•1. Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
•2. To qualify as a subject of Japanese origin (first-generation Japanese), the subject, the subject’s biological parents, and all of the subject’s biological grandparents are of exclusive Japanese descent and have been born in Japan
•3. Age = 20 and = 64 years, both inclusive.
•4. BMI between 18.5 and 25.0 kg·m-2, both inclusive.
•5. FPG = 5.6 mmol/L (100 mg/dL).
•6. Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Known or suspected hypersensitivity to trial product(s) or related products.
•2. Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
•3. Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
•4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction

发起方