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

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Invasive Aspergillosis

Treatments

Drug: Voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01080651

SNUCPT09_Vori2C19_B

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.