Overview

Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Status:
Completed
Trial end date:
2021-08-24
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Esomeprazole
Itraconazole
Criteria
Inclusion Criteria:

- Healthy adult aged ≥ 19 years and ≤ 50 years at the time of screening

- Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 19.0 kg/m2 and
≤ 30.0 kg/m2 at the time of screening

- A subject without any congenital or chronic disease, and has no medical examination
result as pathological symptoms or signs

- A subject who listened to sufficient explanation and fully understood this study, and
voluntarily decided to participate and agreed in writing to comply with the
precautions

- A subject determined eligible for this study by investigator based physical
examination, clinical laboratory tests, interview, etc.

Exclusion Criteria:

- A subject with clinically significant hepatobiliary (severe hepatic impairment, etc.),
renal (severe renal impairment, etc.), neurologic, immunologic, respiratory,
gastrointestinal, endocrine, blood•oncology, cardiovascular (heart failure, Torsades
de pointes, etc.), urinary, or, psychical diseases (except for simple dental past
history such as tartar, impacted tooth, or wisdom tooth) or a history

- A subject who has hypersensitivity to the investigational products, drugs containing
the same class, or other drugs (penicillin and antibiotics, etc.), or a history of
clinically significant hypersensitivity

- A subject with a history of gastrointestinal disorders (gastrointestinal ulcer,
gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or
surgery (except for simple appendectomy and herniotomy) that may affect the safety and
pharmacokinetics of the investigational products

- A subject with the following results in the screening test:

1. Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5

2. QTc interval: > 450 ms

3. Positive serological test (syphilis test, hepatitis B test, hepatitis C test,
human immunodeficiency virus (HIV) test)

- A subject with systolic blood pressure < 80 mmHg or > 160 mmHg, or diastolic blood
pressure < 50 mmHg or > 100 mmHg when vital signs are measured in sitting position
after resting for at least 3 minutes

- A subject with a history of drug abuse

- A subject who administered any prescription drugs or herbal medicine within 2 weeks
prior to the expected date of the first dose, or any over-the-counter drug (OTC drug,
health functional food or vitamin within 1 week prior to the expected date of the
first dose (However, can participate in the study if otherwise decided eligible by the
investigator), or is expected to administer it

- A subject who administered drugs that induce (such as barbitals) or inhibit (such as
clarithromycin) the drug metabolizing enzymes within 1 month prior to the expected
date of the first dose

- A subject who participated in other clinical trial or bioequivalence study within 6
months prior to the expected date of the first dose

- A subject who donated whole blood within 2 months or the component blood within 1
month prior to the expected date of the first dose, or received blood transfusion
within 1 month prior to the expected date of the first dose

- A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure
alcohol), or inability to abstain from drinking from 3 days before the expected date
of the first dose until the last discharge

- A subject with inability to refrain from grapefruit-containing food from 3 days before
the expected date of the first dose until the last discharge

- A subject with excessive caffeine intake (> 5 units/day), or inability to refrain from
caffeine or caffeine-containing food from 3 days before the expected date of the first
dose until the last discharge

- A subject with inability to use a medically acceptable double contraception or
contraception throughout the study and for at least 4 weeks after the last dose, and
with inability to agree to donate sperm until the period