NCT01141270已完成1 期
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study
Polymun Scientific GmbH0 个研究点目标入组 32 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Area under the serum concentration curve (AUC) of FSH
研究概览
简要总结
Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®).
Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers
- •Age between 18-38 years
- •Body mass index 17-29 kg/m2
- •Woman of child bearing potential must agree to practice effective barrier methods for birth control
- •Use of oral contraceptives for at least 3 months before study entry
- •Regular menstruation cycle (25-34 days) before initiation of oral contraception
- •Presence of both ovaries
- •Normal findings in medical history and physical and gynaecological examination unless the investigator considers an abnormality to be clinically irrelevant for this study
- •Signed informed consent
排除标准
- •Polycystic ovary syndrome (PCOS)
- •History of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome, OHSS)
- •Impaired thyroid function (treated or untreated)
- •History of malignant disease
- •AST and/or ALAT > 2 x ULN
- •Other clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
- •Smoking habits of more than 5 cigarettes per day
- •Abuse of alcoholic beverages and drugs
- •Participation in a clinical trial within 3 weeks prior to the study
- •Foreseen inability to attend to scheduled study visits
- •Symptoms of a clinically relevant illness during 3 weeks prior the first study day
- •Pregnancy or lactation period
- •Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study
研究组 & 干预措施
AFOLIA
Experimental
225 IU sc
干预措施: AFOLIA (Drug)
Gonal-f
Active Comparator
225 IU sc
干预措施: Gonal-f (Drug)
结局指标
主要结局
Area under the serum concentration curve (AUC) of FSH
时间窗: 0 -192h after FSH injection
次要结局
未报告次要终点
研究者
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