Hypothyroidism Nutritional, Metabolic, Endocrine
Conditions
Interventions
Cross-over study with three groups. Each of the three treatments is during only 360 minutes: The time required to take the blood samples. A wash-out phase of min. 4 weeks is planned between each treat
Sponsors
University Hospital of Zurich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years 2. Informed Consent as documented by signature
Exclusion criteria
Exclusion criteria: 1. Contraindications to the drugs under study, e.g. known hypersensitivity or allergy 2. Need for any kind of drug therapy for the duration of the study 3. Women who are pregnant or breastfeeding 4. Intention to become pregnant during the course of the study 5. 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 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 child bearing potential. 6. 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.) 7. Abnormal findings in the screening tests (laboratory, ECG, physical examination). 8. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant 9. Participation in another study with investigational drug within the 30 days preceding and during the present study 10. Previous enrolment into the current study 11. Enrolment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of total thyroxin in the serum up to 6 hours after ingestion of levothyroxine, with measurements at 0 min, 30 min, 60 min, 120 min, 240 min and 360 min. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine 2. Tmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine | — |
Countries
Switzerland
Contacts
Public ContactJérôme Bonzon
Outcome results
None listed