Absorption of levothyroxine with breakfast in healthy wome

Not Applicable

Completed

Conditions: Oral levothyroxine
Not Applicable
Thyroid hormones and substitutes

Registration Number: ISRCTN12149022

Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 40

Inclusion Criteria

1. Signed written informed consent before inclusion in the study
2. Age 18–50 years old
3. Body-mass index: 18.5–27 kg/m2
4. Vital signs: systolic blood pressure 100–139 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–90 beats per minute, measured after 5 minutes at rest in the sitting position
5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and comply with the requirements of the entire study
6. Women of child-bearing potential must be using at least one of the following reliable methods of contraception and must continue up to 30 days after the last investigational medicinal product administration: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
6.2. Non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
6.3. Male sexual partner who agrees to use a male condom with spermicide
6.4. Sterile sexual partner
6.5. Non-child-bearing potential or in post-menopausal status for at least 1 year
7. All thyroid function tests within normal limits

Exclusion Criteria

1. Electrocardiogram 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings that could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular (including active arrhythmia or history of arrhythmia, particularly atrial fibrillation), respiratory, skin, haematological, genitourinary or neurological diseases that may interfere with the aim of the study; history of endocrine abnormalities, particularly thyroid, hypophysis and hypothalamus dysfunction; autoimmune diseases such as Basedow-Graves and Hashimoto morbi; neoplasia
6. Medications, including over the counter drugs and herbal remedies for 2 weeks before the start of the study
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study; the 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than one drink per day defined according to the USDA Dietary Guidelines 2010), caffeine (more than five cups of coffee or tea per day) or tobacco abuse (at least 10 cigarettes per day)
10. Positive drug test results at screening or day–1
11. Positive alcohol breath test at day –1
12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study
13. Vegetarians
14. Positive or missing pregnancy test at screening or day–1
15. Pregnant or lactating women