NL-OMON47951已完成2 期
A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF 0.25 MG SEMAGLUTIDE B AND SEMAGLUTIDE D ADMINISTERED SC - Injection site pain experience for 2 formulations of semaglutide
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
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 subjects, aged 18 to 75 years (both inclusive) at the time of
- •signing informed consent.
- •- Body mass index (BMI) >=25.0 kg/m2.
- •- Considered to be generally healthy based on the medical history, physical
- •examination, and the results of vital signs, electrocardiogram, 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 4
- •weeks of Day 1 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 (HbA1c) equal to or above 6.5 % (48 mmol/mol) at
- •- Use of prescription medicinal products or non prescription drugs or herbal
- •products, except routine vitamins, topical medication, contraceptives, and
- •occasional use of 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
- •- 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 the 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 study requirements.
研究者
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