NL-OMON50416已完成不适用
An open-label, randomized, single center, crossover study in healthy participants to assess lipoprotein lipase activity and levels, and triglyceride levels after heparin exposure, in both fasted and postprandial state - Investigation of biomarkers after heparin use
ovo Nordisk0 个研究点目标入组 12 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
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Informed consent obtained before any study-related activities. Study-related
- •activities are any procedures that are carried out as part of the study,
- •including activities to determine suitability for the study.
- •2. Healthy male or female, aged 18 years to 65 years (both inclusive) at the
- •time of signing informed consent.
- •3. Body mass index 18.0 kg/m2 to 29.9 kg/m2 (both inclusive) at the time of
- •signing informed consent.
- •4. Body weight >=50 kg at the time of signing informed consent.
- •5. Considered to be generally healthy as judged by the Investigator, as defined
- •by the absence of any clinically significant, active, or chronic disease
- •evidenced by a detailed medical and surgical history and a complete physical
- •examination including vital signs, 12 lead ECGs, hematology, clinical
- •chemistry, coagulation, urinalysis, and serology.
排除标准
- •1. Previous participation in the current study.
- •2. Employee of PRA or the Sponsor.
- •3. History of relevant drug and/or food allergies.
- •4. Known or suspected allergy to study drug-related products, including heparin
- •or pork products.
- •5. Using tobacco products within 60 days prior to the first drug
- •administration.
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