JPRN-jRCT2080225283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 SAR342434 to Humalog 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 <= 45age old（—）
- 性别
- Male
入选标准
- •Japanese male subjects, between 20 and 45 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.
- •- Normal 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 lispro or any of the excipients.
研究者
相似试验
已完成
1 期
Comparison of Exposure and Activity of SAR341402 to NovoRapid in Healthy Japanese Male SubjectsHealthy volunteersJPRN-jRCT2080225284Sanofi K.K.36
尚未招募
Unknown
A Single Dose Two-Way Crossover Oral Bioavailability Study Of The Study Product (BerbiQ) Which Contains Berberine, In Healthy, Adult, Human Subjects Under Fasting Conditions.CTRI/2024/07/070781Molecules Biolabs Pvt Ltd
尚未招募
Unknown
A Single Dose, Two-Treatment,Oral Bioavailability Study Of the Product Containing VitaminC in Healthy, Adult, Human Subjects Under Fasting Conditions.CTRI/2024/07/070710Molecules Biolab Pvt Ltd
Unknown
不适用
Comparative pharmacokinetic and Pharmacodynamic trial of Wosulin R Insulin Injection (in comparision with Human Actrapid HM penfil insulin injection) in healthy human adult volunteersCTRI/2015/05/005801Wockhardt Ltd India48
尚未招募
不适用
A randomized, double-blind, two-treatment, single-period, single-dose, parallel design, comparative bioavailability study between RTPR- 021 (test adalimumab) and Humira® (reference adalimumab).CTRI/2015/02/005524Reliance Life Sciences Pvt Ltd120