A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)0-∞
研究概览
简要总结
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
详细描述
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male vulunteers aged 18 and above.
- •The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
排除标准
- •Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
- •Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
- •Participation in another clinical trial within 3 months.
- •Smoking more than 5 cigarettes per day during the 3 months prior to screening.
- •Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- •Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.
研究组 & 干预措施
Liraglutide injection
干预措施: Liraglutide injection (Drug)
Liraglutide injection(Victoza®)
干预措施: Liraglutide injection(Victoza®) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)
时间窗: 40 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
次要结局
- Incidence of Treatment-Emergent Adverse Events(40 days)