NCT00761540已完成1 期
A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.
研究概览
简要总结
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any trial related activities
- •Healthy Chinese male subjects
- •Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
- •Fasting plasma glucose less than 6.0 mmol/L
- •Non-smoker
排除标准
- •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
- •Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- •Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
- •Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.
研究组 & 干预措施
A1
Experimental
干预措施: liraglutide (Drug)
A2
Placebo Comparator
干预措施: placebo (Drug)
B1
Experimental
干预措施: liraglutide (Drug)
B2
Placebo Comparator
干预措施: placebo (Drug)
C1
Experimental
干预措施: liraglutide (Drug)
C2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.
时间窗: After 21 days of treatment
次要结局
- AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)(After 1 day of treatment)
- Adverse events(After 21 days of treatment)
- Hypoglycaemic events(After 21 days of treatment)
研究者
研究点 (1)
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