NL-OMON45253已完成不适用
A randomized, double-blind, three-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single 6 mg subcutaneous administration of the<br>proposed biosimilar product LA-EP2006, Neulasta® US and Neulasta® EU in healthy subjects - PK bioequivalence, PD equivalence of LA-EP2006, Neulasta US and Neulasta E
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
- 136
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 64（—）
入选标准
- •- healthy male and female volunteers
- •- age 18 - 55 years, inclusive
- •- BMI 19.0 - 30.0 kg/m2, inclusive
- •- weight * 60 kg
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 12 weeks from the start of the study.
研究者
相似试验
已完成
1 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 1: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing prototype skin patchesISRCTN21827000Dstl18
已完成
不适用
A double-blind, randomized, three-way cross-over trial to develop a pharmacologic challenge with ketamine.schizophreniapsychotic disorder10039628NL-OMON34124Centre for Human Drug Research24
进行中（未招募）
不适用
Randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on postural instability of melatonin and zolpidem in healthy elderly subjectsEUCTR2008-002164-34-DEH. Lundbeck A/S
进行中（未招募）
1 期
It is the aim of this study to analyse the blood flow in small blood vessels (capillaries) in diabetic patients before and after two different single doses of BAY 1193397 (1 mg and 5 mg tablets) and placebo. In order to see if the study drug is effective, BAY 1193397 tablets will be compared to placebo tablets.Treatment of diabetic foot ulcerMedDRA version: 20.0 Level: LLT Classification code 10012684 Term: Diabetic peripheral vascular disease System Organ Class: 100000004866EUCTR2015-003799-63-GBBayer AG22
招募中
不适用
A randomized, double-blind, two-way cross-over study to determine the effects of levetiracetam on corticospinal excitability in patients with treatment-controlled epilepsy, as measured by single and paired pulse TMS-EMG and TMS-EEG10039911EpilepsyNL-OMON49353Centre for Human Drug Research32