Single-Blind, Randomized, Comparative, Phase I Study to Evaluate the Tolerability, Safety, and Pharmacokinetic Characteristics of Human Chorionic Gonadotropin Between Two Recombinant hCG Products, DA-3803 Injection and Ovidrel Liquid Injection, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Concentration in serum of hCG examined by non-compartmental analysis
研究概览
简要总结
This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No medical history relating to the alimentary system, liver system, heart system, haematological disease
- •Ideal body weight +/- 20%
排除标准
- •acute disease within 28 days
- •medical history that might affect the absorption, distribution, secretion, metabolism of drugs
- •metrectomy surgery
- •desexualization
- •tubal ligation
- •menopause
- •pregnancy
- •not able to use contraception
- •drink alcohol more than 14 units/week
- •smoker who smokes 10 or more cigarettes
研究组 & 干预措施
T-R (Test-Reference drug)
DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
干预措施: T-R (Test-Reference drug) (Drug)
R-T (Reference-Test drug)
Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
干预措施: R-T (Reference-Test drug) (Drug)
结局指标
主要结局
Concentration in serum of hCG examined by non-compartmental analysis
时间窗: 3 weeks
Examine the following: * Maximum blood concentration * Travel time of maximum blood concentration * half time t(1/2) * Clearance * Volume of distribution
次要结局
未报告次要终点