ISRCTN73459064进行中（未招募）Unknown
Single centre drug-drug interaction study with levothyroxine and zinc-D-gluconate in healthy subjects
niversity Hospital of Zurich0 个研究点目标入组 15 人开始时间: 2024年8月14日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •1. Age 18-65 years old
- •2. Informed Consent as documented by signature
排除标准
- •1. Contraindications to the drugs under study, e.g. known hypersensitivity or allergy
- •2. Need for any kind of oral drug therapy (including oral contraceptive or nutritional supplements) for the duration of the study, except for the symptomatic treatment of common conditions like headache, musculoskeletal pain, common cold, gastritis, nausea and diarrhoea with medication containing paracetamol, non-steroidal anti-inflammatory drugs, meclizine, domperidone, and loperamide, as long they are taken on an as-per-need basis and not 72 hours before a visit.
- •3. Planned intake of oral calcium, magnesium, zinc or iron supplements for the duration of the study
- •4. Other clinically significant concomitant disease states (e.g., renal failure, thyroid dysfunction, cardiovascular disease, arterial hypertension, any other medical condition that could lead to an albumin deficiency such as anorexia etc.)
- •5. Abnormal findings in the screening tests (laboratory, ECG, physical examination).
- •6. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •7. Participation in another study with an investigational drug within the 30 days preceding and during the present study
- •8. Previous enrolment into the current study
- •9. Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Applicable only to female participants:
- •1. Women who are pregnant or breastfeeding
- •2. Intention to become pregnant during the study
- •3. Lack of safe contraception, defined as female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception (defined as sexual abstinence with men (except in case of medically proven male sterility of the male sexual partner), use of a condom, use of an intrauterine device (contraceptive coil with or without hormones), use of a dermal or subcutaneous device or a subcutaneous injection with hormones (such as Evra® or Implanon®), use of a vaginal hormonal device (such as NuvaRing®)) for the entire study duration. Female participants who are surgically sterilised / hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
研究者
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