NL-OMON45782已完成不适用
A randomized, open-label, two-period, crossover study to determine the pharmacokinetics of reconstituted lyophilized Erelzi and Enbrel® (US-licensed) following a single subcutaneous injection in healthy male subjects. - Erelzi/Enbrel 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
- 56
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
- •Male subjects
- •18 to 55 years, inclusive
- •Weight 50 - 99.9 kg
- •BMI 19.0 - 29.9 kg/m2 inclusive ;5. Subject is affiliated with social security or equivalent system
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
相似试验
已完成
不适用
A study in healthy subjects to explore the blood levels of a drug when released from the IntelliCap capsule as compared to a marketed drug capsulePharmaceutical research and developmentISRCTN45336965Medimetrics Personalized Drug Delivery B.V. (Netherlands)14
已完成
1 期
An open-label, randomized, two-period crossover study to compare the pharmacokinetic and safety profile of single dose of TAK-070 (50 mg) under fed and fasting condition in healthy volunteerAlzheimer's diseases diseaseJPRN-UMIN000018040nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital8
尚未招募
1 期
A study to find out the difference in absorption of same dose of drug prepared in 2 different forms, given one followed by the other to the same persoCTRI/2009/091/000628ovartis Healthcare Private Limited16
进行中（未招募）
1 期
A study to compare how easily patients with breathing conditions (asthma, chronic obstructive pulmonary disease (COPD) and asthma COPD overlap syndrome) can use two different types of inhaler.EUCTR2014-004564-38-DEMundipharma Research Limited368
进行中（未招募）
1 期
A study to compare how easily patients with breathing conditions (asthma, chronic obstructive pulmonary disease (COPD) and asthma COPD overlap syndrome) can use two different types of inhaler.EUCTR2014-004564-38-GBMundipharma Research Limited369