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CompletedNCT01080651Updated Aug 19, 2011

Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole

A Phase 1 interventional study of Voriconazole in Invasive Aspergillosis, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-19.

Sponsored by Seoul National University Hospital · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole

02

Conditions studied

  • Invasive Aspergillosis
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.Healthy male subjects aged 20 - 50 years.
  • 2.A body mass index (BMI) in the range 17-28 kg/m2.
  • 3.Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures.

Exclusion criteria

Exclusion Criteria:

  • 1.Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
  • 2.Clinically relevant abnormal medical history that could interfere with the objectives of the study.
  • 3.Presence or history of eye disease or eye field defect.
  • 4.A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
  • 5.A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
  • 6.A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
  • 7.Presence or history of drug abuse.
  • 8.Participation in other clinical trial within 2 months.
  • 9.Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
  • 10.Blood donation during 2 months or apheresis during 1 month before the study.
  • 11.Presence or history of alcohol abuse.
  • 12.Smoking of more than 10 cigarettes/day.
  • 13.Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
  • 14.Subject judged not eligible for study participation by investigator.
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    CYP2C19 extensive metabolizer

    Drug: Voriconazole

  • Active comparator
    CYP2C19 poor metabolizer

    Drug: Voriconazole

Interventions

  • DrugVoriconazole

    Day1: voriconazole 200 mg x 2, oral administration, Day2-7: rifampin 600 mg, once a day oral administration, Day8: voriconazole 200 mg x 2 + rifampin 600 mg, oral co-administration

06

What researchers measure

Primary outcomes

  1. Plasma concentration of voriconazole

    Sample for concentration measurement conducted before and after rifampicin treatment as same manner

    Time frame: pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose

07

Study locations

1 site
  • Seoul National University Hospital Clinical Trial Center
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01080651
Lead sponsor
Seoul National University Hospital
First posted
Mar 4, 2010
Start date
Dec 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Aug 19, 2011

Study contacts

In-Jin Jang, M.D., Ph.D.
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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