Status:

COMPLETED

Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

Lead Sponsor:

University of Zurich

Conditions:

Physiological Effects of Vitamin D

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

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 fe...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • male or female
  • age 18 to 65 years at study entry
  • signed informed consent form
  • Body Mass Index \> 18 - \< 30 kg/m2
  • Participants must not have any other diseases (as assessed by the screening examination)
  • Participants must not take any concomitant medications except oral contraceptives in females
  • Normal blood count
  • Exclusion criteria:
  • Subjects with confirmed or suspected hypersensitivity towards the study medications
  • Contemporaneous participation in any other study
  • Females only: pregnancy
  • Females only: breast-feeding
  • Clinically significant abnormal laboratory findings
  • Known or suspected present or past malignancies of any kind
  • Known or suspected active infections, serious infections in the preceding 3 months
  • Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
  • Subjects known or suspected not to comply with the study regulations
  • Subjects employed at the participating departments of the University Hospital Zürich.
  • Known or suspected present or past diseases which may interfere with the study
  • smokers
  • alcohol or drug abuse

Exclusion

    Key Trial Info

    Start Date :

    May 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2013

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT01856348

    Start Date

    May 1 2013

    End Date

    July 1 2013

    Last Update

    August 13 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology

    Zurich, Canton of Zurich, Switzerland, 8091

    Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers | DecenTrialz