Comparing the fraction of Vitamin D3 that reaches the blood circulation in healthy volunteers after a single dose of either a marketed liquid medication or a new form of the medication that is dissolvable in the mouth

Phase 1

Completed

• Conditions: Vitamin D deficiency; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13208948
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35034345/ (added 17/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-22
• Study Start: 2020-11-27
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Signed written informed consent before inclusion in the study
2. Aged 40-70 years inclusive
3. Body Mass Index (BMI) 20-29 kg/m² inclusive
4. Systolic blood pressure between 100-139 mmHg, diastolic blood pressure between 50-89 mmHg, heart rate between 50-90 bpm (all measured after 5 min at rest in the sitting position)
5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects, and to co-operate with the investigator, and to comply with the requirements of the entire study
6. Women of childbearing potential must be using at least one of the following reliable methods of contraception:
6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
6.2. A 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. A male sexual partner who agrees to use a male condom with spermicide
6.4. A sterile sexual partner
7. Female participants of non-child-bearing potential or in post-menopausal status for at least one year will be admitted
8. For all women, pregnancy test result must be negative at screening and Day -1

Exclusion Criteria

1. Clinically significant abnormalities on 12-lead (supine position) electrocardiogram (ECG)
2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Clinically significant abnormal laboratory values indicative of physical illness, especially hypercalcemia and hypercalciuria
4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, history of anaphylaxis to drugs, or history of allergic reactions in general which the investigator considers may affect the outcome of the study
5. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases that may interfere with the aim of the study, especially sarcoidosis, kidney failure, nephrolithiasis, nephrocalcinosis, or liver failure
6. Medications including over the counter (OTC) medications, herbal remedies, and supplements, especially those containing calcium, magnesium or vitamin D, for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapy for women will be allowed.
7. Participation in the evaluation of any investigational product within the 3 months of the first day of 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 within the 3 months of the first day of this study
9. History of drug, alcohol (>1 drink/day for women and >2 drinks/day for men), caffeine (>5 cups/day of coffee or tea) or tobacco abuse (=10 cigarettes/day)
10. Positive result at the drug test at screening or Day -1
11. Positive alcohol breath test at Day -1
12. Abnormal diets (<1600 or >3500 kcal/day), substantial changes in eating habits within 4 weeks of the first day of this study, vegetarian diet; or high vitamin D and calcium dietary intake within 4 weeks of the first day of this study
13. Exposure to strong sunlight or UV sources within 2 weeks of the first day of this study
14. Pregnant or lactating women or a positive or missing pregnancy test at screening or Day -1

Study & Design

• Study Type: Interventional
• Study Design: Not specified