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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Voriconazole

Criteria

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.