Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- AUC28-56d
研究概览
简要总结
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-28 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
- •In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
- •Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
- •Fully understood and voluntarily signed the informed consent form
- •With high compliance
排除标准
- •With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
- •Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
- •With gastrointestinal disease
- •Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
- •With alcohol consumption > 2 units/d within 6 months before screening
- •With cigarette consumption > 5/d within 3 months before screening
- •Donated or lost blood > 400 mL within 3 months before screening
- •Hospitalized or received surgery within 3 months before screening
- •Received study drug of other clinical trial within 3 months before screening
- •Received prescription drug within 14d before dosing
- •Received over-the-counter drug or herb within 48h before dosing
- •Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing
- •Consumed alcohol within 48h before dosing or positive for breath alcohol test
- •Cannot consume standard meal
- •Intolerable to venipuncture
- •Cannot receive intramuscular injection in the glute
- •With vitamin B12 deficiency
- •Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing
- •For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing
- •Other reason judged by investigators
研究组 & 干预措施
Test
干预措施: The test octreotide microsphere (Drug)
Reference
干预措施: The reference octreotide microsphere (Drug)
结局指标
主要结局
AUC28-56d
时间窗: Day 28-56
The area under the concentration-time curve from Day 28 to Day 56
AUC0-∞
时间窗: Day 0-82
The area under the concentration-time curve extrapolated to infinity
AUC0-t
时间窗: Day 0-82
The area under the concentration-time curve from dosing to the last quantifiable time-point
Cmax
时间窗: Day 0-82
The maximum drug concentration
AUC0-28d
时间窗: Day 0-28
The area under the concentration-time curve from dosing to Day 28
次要结局
未报告次要终点