DRKS00012972已完成未知
Dose-escalation study to evaluate safety and tolerability of cellobiose in healthy subjects - PLA/012617
Pfeifer & Langen GmbH & Co. KG0 个研究点目标入组 48 人开始时间: 2017年10月16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
- 48
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Men and women, 18 to 65 years old
- •2. BMI 18.5 to 29.9 kg/m2
- •3. Generally in good health without clinically significant findings at V1
- •4. Readiness to comply with study procedures, in
- •particular:
- •- consumption of the IP as recommended
- •- filling in the subject diary and questionnaire
- •- keeping habitual diet and level of physical
- •exercise and avoiding excessive exercise
- •- avoiding food that contains indigestible or less digestible ingredients such as oligosaccharides or sugar alcohols
- •- avoiding intake of yogurt
- •5. Women of childbearing potential:
- •- negative pregnancy testing (beta HCGtest
- •in urine) at V1
- •- commitment to use contraception methods during the study.
- •Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
排除标准
- •1. Known allergy or hypersensitivity to the components of the investigational product
- •2. History and/or presence of clinically significant self-reported disorder as per investigator’s judgement:
- •- untreated or non-stabilized thyroid gland disorder
- •- untreated or non-stabilized Hypertension (regular systolic blood pressure =
- •140 mmHg and/or diastolic blood pressure = 90 mmHg)
- •- digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis
- •- food allergy and known food intolerances (e.g. lactose, fructose)
- •- diarrhea within the preceding week or reported recurrent diarrhea
- •- any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- •3. Gastrointestinal Symptom Rating Scale (GSRS) at V1 (1 week recall)
- •- any symptom scoring > 3
- •- total mean score > 2
- •4. Deviation of laboratory parameter(s) at V1 that is:
- •- clinically significant or
- •- 2x ULN/LLN (upper limit of normal/ lower limit of normal), unless the deviation is justified by a previous known not clinically relevant condition, e.g. Gilbert’s syndrome
- •5. Any regular medication and/or Supplementation that could interfere with the conduct / evaluation of the trial as per investigator’s
- •6. Previous relevant bowel surgery according to the investigator’s judgement
- •7. Pregnancy or nursing
- •8. History of or current abuse of drugs, alcohol or medication
- •9. Plans to travel during the study period
- •10. Participation in another clinical study in the
- •30 days prior to V1 and during the study
- •11. Any other reason for exclusion as per investigator’s judgement, e.g. insufficient compliance with study procedures
研究者
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