NL-OMON50101已完成不适用
A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection - Injection site pain comparison of excipient solutions
ovo Nordisk0 个研究点目标入组 108 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
- 108
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 or female, aged 18 to 69 years (both inclusive) at the time of signing
- •informed consent.
- •BMI >=25.0 and <30.0 kg/m2.
- •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.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant within 1
- •week of Day 2 or is of childbearing potential and not using highly effective
- •contraceptive methods.
- •Any disorder which in the Investigator*s opinion might jeopardise subject*s
- •safety, evaluation of results, or compliance with the protocol.
- •Glycated haemoglobin (HbA1c) >=6.5 % (48 mmol/mol) at screening.
- •Use of prescription medicinal products or non-prescription drugs or herbal
- •products, except routine vitamins, topical medication (when not used in the
- •abdominal area), contraceptives or occasional use of paracetamol (not allowed
- •within 24 hours prior to Trial Product administration), within 14 days prior to
- •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 centre.
- •Use of tobacco and nicotine products, defined as any of the below:
- •-Smoking more than 1 cigarette or the equivalent per day on average.
- •-Not able or willing to refrain from smoking and use of nicotine substitute
- •products during the in-house period.
- •Subject is not able to understand and read English or Dutch, or subject is not
- •able to understand and comply with the trial requirements.
研究者
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