Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

NCT ID: NCT01856348

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

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

Conditions

Physiological Effects of Vitamin D

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1, 25 dihydroxyvitamin D3 intake

This is a single arm study.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Interventions

Vitamin D

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerd A Kullak-Ublick, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Pharmacology and Toxicology

Locations

University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

PHA-11-VID/FOL-01

Identifier Type: -

Identifier Source: org_study_id