NCT03324061已完成1 期
A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female 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
- 600
- 试验地点
- 12
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.
详细描述
This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2
- •Body weight of at least 50 kg at screening
- •Good health as determined by evaluations
- •Negative serum pregnancy test
- •Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL
- •Subjects who are peri-menopausal and experiencing at least one of specified symptoms of menopause (eg, hot flashes, mood swings, night sweats, and others)
- •Negative urine test for drugs of abuse
- •Negative urine test for HIV antibody, HBsAG, and HCV at Screening
- •Women of child-bearing potential must agree to consistently practice contraception throughout the duration of the study and continue to do so for 1 year after receiving study drug by one of the following methods: abstinence, condom, diaphragm or cervical cap with spermicide, intrauterine device or male partner had previously undergone a vasectomy as declared in medical history
排除标准
- •Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study
- •Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator
- •Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study
- •Concomitant medication that can affect bleeding
- •Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant
- •Subjects with QTcF interval duration >470 milliseconds
- •History of alcoholism or drug addiction within 1 year prior to Day 1
- •History of allergy or a known sensitivity to product components of fulvestrant Test and Reference formulations
- •Creatinine clearance <60 mL/minute based on the Cockcroft-Gault equation
- •Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to Day 1
- •Previous exposure to fulvestrant
- •Familial relationship with another study participant
研究组 & 干预措施
Fulvestrant for Injectable Suspension
Experimental
Fulvestrant for Injectable Suspension (500 mg/vial)
干预措施: Fulvestrant for Injectable Suspension (Drug)
Faslodex (R)
Active Comparator
Faslodex (250 mg/mL)
干预措施: Faslodex (Reference) (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: Day 0 through Day 140
Area under the concentration-time curve(AUC)
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
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