Drug interaction study with thyroid hormone and zinc preparation in healthy volunteers
- Conditions
- HypothyroidismNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN73459064
- Lead Sponsor
- niversity Hospital of Zurich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 15
1. Age 18-65 years old
2. Informed Consent as documented by signature
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of total thyroxin in the serum up to 6 hours after ingestion of levothyroxine measured using electrochemiluminescence immunoassay (ECLIA) at 0, 30, 60, 120, 240 and 360 min
- Secondary Outcome Measures
Name Time Method 1. Cmax of total thyroxin in the serum measured using electrochemiluminescence immunoassay (ECLIA) during a 6-hour period after ingestion of levothyroxine<br>2. Tmax of total thyroxin in the serum measured using electrochemiluminescence immunoassay (ECLIA) during a 6-hour period after ingestion of levothyroxine