EUCTR2019-002284-10-NL进行中（未招募）1 期
A TRIAL TO COMPARE THE INJECTION SITE EXPERIENCE OF 0.25 MG SEMAGLUTIDE SC ADMINISTERED BY 2 DIFFERENT PRODUCTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent
- •- Body mass index (BMI) equal to or above 25.0 kg/m^2
- •- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •- Woman who is pregnant or breast-feeding or intends to become pregnant within 4 weeks after administration of the study drug, or is of childbearing potential and not using highly effective contraceptive methods with her fertile male sexual partner
- •- Any disorder that in the Investigator’s opinion might jeopardize subject’s safety, evaluation of results, or compliance with the protocol
- •- Glycosylated hemoglobin =6.5% at screening
- •- Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives, and occasional use of paracetamol (paracetamol not allowed within 24 hours prior to drug administration), within 14 days prior to drug administration
- •- Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits
- •- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center
- •- Use of tobacco and nicotine products, defined as any of the below:
- •a) Smoking more than 1 cigarette or the equivalent per day on average
- •b) Not able or willing to refrain from smoking and the use of nicotine substitute products during the inhouse period
- •- Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the study requirements
研究者
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