Physiological Effects of Vitamin D Clinical Trial
Official title:
Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers
| Verified date | August 2013 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
The study is conducted to assess the effect of a vitamin D3 supplementation on the
activities of two intestinal transporters and on the pharmacokinetics of the transporter
substrates folic acid and fexofenadine.
- Trial with medicinal product
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion criteria: 1. male or female 2. age 18 to 65 years at study entry 3. signed informed consent form 4. Body Mass Index > 18 - < 30 kg/m2 5. Participants must not have any other diseases (as assessed by the screening examination) 6. Participants must not take any concomitant medications except oral contraceptives in females 7. Normal blood count Exclusion criteria: 1. Subjects with confirmed or suspected hypersensitivity towards the study medications 2. Contemporaneous participation in any other study 3. Females only: pregnancy 4. Females only: breast-feeding 5. Clinically significant abnormal laboratory findings 6. Known or suspected present or past malignancies of any kind 7. Known or suspected active infections, serious infections in the preceding 3 months 8. Positive hepatitis B, hepatitis C and / or HIV 1/2 serology 9. Subjects known or suspected not to comply with the study regulations 10. Subjects employed at the participating departments of the University Hospital Zürich. 11. Known or suspected present or past diseases which may interfere with the study 12. smokers 13. alcohol or drug abuse |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D | Changes in single-dose pharmacokinetics of racemic fexofenadine at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution. | 10 days | No |
| Primary | Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D | Changes in single-dose pharmacokinetics of folic acid at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution. | 10 days | No |
| Secondary | Number and characteristics of participants with adverse events | 10 days | Yes | |
| Secondary | transporter mRNA quantity | Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake. | 10 days | No |