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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, 25 dihydroxyvitamin D3 intake | Experimental | This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and characteristics of participants with adverse events | 10 days | |
| transporter mRNA quantity | Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerd A Kullak-Ublick, Prof MD | University Hospital Zurich, Pharmacology and Toxicology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 10 days |