Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
- Registration Number
- NCT01080651
- Lead Sponsor
- Seoul National University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CYP2C19 poor metabolizer Voriconazole - CYP2C19 extensive metabolizer Voriconazole -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital Clinical Trial Center
🇰🇷Seoul, Korea, Republic of