DRKS00017848已完成未知
Dose-escalation study to evaluate safety and gastrointestinal tolerability of allulose in subjects compared to placebo - 1370all19ct
Pfeifer & Langen GmbH & Co. KG0 个研究点目标入组 49 人开始时间: 2019年8月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Subjects of both genders, who will be included, must fulfil all the following criteria: 1. sex: male/female 2. ethnic origin: Caucasian 3. age: 18 years or older 4. body-mass index2 (BMI): = 18.5 kg/m² and = 30.0 kg/m² 5. good state of health 6. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
排除标准
- •Safety concerns 1. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the IPs 2. subjects with known diabetes mellitus Typ I and II reported in medical history 3. existing gastrointestinal diseases (e.g. inflammatory bowel disease, coeliac disease, pancreatitis) and/or pre-existing operations of digestive system, which might interfere with the GI-tolerance 4. malabsorption, current or known in history 5. subjects reporting any regular disturbances of the gastrointestinal motility, flatulence, constipation or diarrhoea 6. untreated or non-stabilized thyroid gland disorder 7. untreated or non-stable hypertension 8. known allergic reactions or hypersensitivity to the components of the IP used 9. subjects with known a food allergies unless it is judged as not relevant for the clinical trial by the investigator
- •Lack of suitability for the clinical trial 10. acute or chronic diseases which may interfere with the aims of the clinical trial 11. history of or current drug or alcohol dependence 12. regular intake of alcoholic food or beverages of = 24 g pure ethanol for male or = 12 g pure ethanol for female per day 13. subjects who are on a diet which could affect the GI-transit 14. regular intake of caffeine containing food or beverages of = 500 mg caffeine per day 15. administration of any investigational medicinal product during the last month prior to individual enrolment of the subject 16. regular treatment with any medication impairing or influencing the gastrointestinal transit time (e.g. laxatives, medication against diarrhoea, antibiotics) or within the last 2 weeks before individual enrolment of the subject 17. subjects, who report a frequent occurrence of migraine attacks
- •For female subjects with childbearing potential only: 18. positive pregnancy test at screening examination 19. pregnant or lactating women 20. female subjects who do not agree to apply highly effective contraceptive methods
- •Administrative reasons 21. subjects suspected or known not to follow instructions 22. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
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