Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of Leuprorelin
研究概览
简要总结
A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.
详细描述
To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy menopausal female
- •β-hCG is negative at screening and before administration of investigational drug
- •Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc...
- •Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 25
排除标准
- •History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
- •Uncontrolled diabetes mellitus
- •Pregnancy or breast feeding
- •History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
- •Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
- •Has abnormal function of liver and kidney at screening
研究组 & 干预措施
LeuplinⓡInj
LeuplinⓡInj(=leuprorelin acetate 3.75mg)
干预措施: LeuplinⓡInj (Drug)
CKD-841
CKD-841(=leuprorelin acetate 3.75mg)
干预措施: CKD-841 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Peak Plasma Concentration (Cmax) in ng/mL
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL
Follicular Stimulating Hormone(FSH) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Follicular Stimulating Hormone(FSH) in IU/L
The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
The time -to-maximal serum or plasma concentrations (Tmax) in hr
Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L
Estradiol of Leuprorelin
时间窗: From before injection to up to 1008 hours post injection
Estradiol in pg/ml
次要结局
- Safety Assessment by evaluating adverse events(AEs).(From day1 to day 56)