Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01856348

Enrollment

Registered

2013-05-17

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological Effects of Vitamin D

Brief summary

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

Interventions

DRUGVitamin D

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D	10 days	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.
Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D	10 days	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.

Secondary

Measure	Time frame	Description
Number and characteristics of participants with adverse events	10 days	—
transporter mRNA quantity	10 days	Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026