NL-OMON40923已完成不适用
A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects - GP2015 bioequivalence study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hexal AG
- 入组人数
- 51
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
- •- Subjects must give written informed consent before any assessment is performed;- Male subjects, aged 18 to 55 years inclusive ;- Physically and mentally healthy, as determined by physical examination and safety laboratory;- Body weight between 50 to 140 kg and body mass index (BMI) between 18.5 to 49.9 kg/m2 inclusively;- Non-smoker or ex-smoker, defined as not having smoked for at least 6 months before IMP administration
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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