NL-OMON37820已完成不适用
An open-label, randomized, two-period, two-sequence crossover, single-center trial to assess the bioequivalence of a single dose of 600 IU of freeze-dried r-hLH (Luveris®) versus a single 600 IU dose of the liquid formulation of Luveris® in the Pre-Filled Pen, administered subcutaneously (SC) in pituitary suppressed healthy premenopausal female subjects. - BE study of freeze-dried Luveris vs Luveris in pre-filled pen
Merck Sharp & Dohme (MSD)0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •healthy female subjects
- •18-40 yrs, inclusive
- •BMI: 18.5-30.0 kg/m2, inclusive, and weigh more than 50 kg
- •non-smoking or smoking less then 5 cigarettes per day
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
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