JPRN-jRCT2080225284已完成1 期
A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Study to Compare Exposure and Activity of SAR341402 to NovoRapid Using the Euglycemic Clamp Technique, in Healthy Japanese Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi K.K.
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized, Masking: Double blind, Design: Crossover
入排标准
- 年龄范围
- >= 20age old 至 <= 55age old（—）
- 性别
- Male
入选标准
- •Japanese male subjects, between 20 and 55 years of age, inclusive.
- •- Body weight between 50.0 and 90.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m^2, inclusive.
- •- Certified as healthy by a comprehensive clinical assessment.
- •- Normal vital signs.
- •- Standard 12-lead electrocardiogram parameters.
- •- Laboratory parameters within the normal ranges.
排除标准
- •- Any history or presence of clinically relevant medical disorders.
- •- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- •- Symptomatic postural hypotension or asymptomatic postural hypotension.
- •- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •- History or presence of drug or alcohol abuse.
- •- Any subject who has participated in any other clinical study prior to study.
- •- Known hypersensitivity to insulin aspart or any of the excipients.
研究者
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