ISRCTN18075783
Active, Not Recruiting
Phase 4
Single Centre Drug-Drug Interaction study with Levothyroxine/Magnesium-Citrate and Levothyroxine/Magnesium-Aspartate in healthy subjects
niversity Hospital of Zurich0 sites12 target enrollmentOctober 17, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hypothyroidism
- Sponsor
- niversity Hospital of Zurich
- Enrollment
- 12
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 18\-65 years
- •2\. Informed Consent as documented by signature
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
Outcomes
Primary Outcomes
Not specified
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