Drug interaction study with thyroid hormone and magnesium preparation in healthy volunteers

Phase 4

• Conditions: Hypothyroidism; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN18075783
• Lead Sponsor: niversity Hospital of Zurich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-17
• Last Update Posted: 30 October 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 12

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
11. Enrolment of the investigator, his/her family members, employees and other dependent persons

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, with measurements at 0 min, 30 min, 60 min, 120 min, 240 min and 360 min.

Secondary Outcome Measures

Name	Time	Method
1. Cmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine<br>2. Tmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine