Invasive Aspergillosis
Conditions
Brief 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
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
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of voriconazole | pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose | Sample for concentration measurement conducted before and after rifampicin treatment as same manner |
Countries
South Korea
Outcome results
None listed