| Eligibility |
Inclusion Criteria:
1. Healthy male Korean, Chinese, or Caucasian adults at the age of =19 to =50 years old
at the time of written informed consent:
2. Body weight =55.0 kg AND body mass index (BMS) =18.0 kg/m2 to <30.0 kg/m2 at
screening: BMI(kg/m2) = body weight (kg) / {height (m)}2
3. The subject must voluntarily decide to participate in the study after being informed
of, and fully understanding, details of the study; written informed consent must be
obtained prior to any of the screening procedures.
4. Eligible for this study as determined by the investigator based on physical
examinations, clinical laboratory tests, and interviews.
Exclusion Criteria:
1. Evidence or history of clinically significant hepatic, renal, neurological,
respiratory, endocrine, blood and tumor, cardiovascular, urinary, and psychiatric
disorders.
2. Evidence or history of gastrointestinal disorders (gastrointestinal ulcer, gastritis,
gastrodynia, gastroesophageal reflux disease, Crohn's disease, etc.) that might affect
the safety and PK of IP and/or history of gastrointestinal surgery (except for simple
appendectomy and hernia repair).
3. Hypersensitivity to drugs or history of any clinically significant hypersensitivity.
4. Any of the following screening test results:
- Hemoglobin level < 12.0 g/dL
- Creatinine clearance: <60 mL/min/1.73m2 as calculated by the equation of
Modification of Diet in Renal Disease
- QTc interval: > 450 ms
- Positive serum tests (hepatitis B, hepatitis C, human immunodeficiency virus,
syphilis)
5. Screening systolic blood pressure <90 mmHg or >150 mmHg and/or diastolic blood
pressure <60 mmHg or >100 mmHg as measured in sitting position after =3 minutes of
rest.
6. History of drug abuse or a positive urine screening test for drugs of abuse.
7. Prior or expected treatment with any prescription drugs or herbal medicine within 2
weeks and/or any over the counter drugs, health functional foods, or vitamins within 1
week prior to the planned first IP dosing (individuals who are determined to be
eligible at the discretion of the investigator based on other criteria will be allowed
to participate in the study).
8. Treatment with drug metabolizing enzyme inducers and/or suppressors such as barbitals
within 1 month prior to the planned first IP dosing.
9. Having participated in another clinical trial or a bioequivalence study and
administered any IP within 6 months prior to the planned first IP dosing in the
present study.
10. Whole blood donation within 2 months and/or apheresis donation within 1 month and/or
blood transfusion within 1 month prior to the planned first IP dosing.
11. Continuous, excessive caffeine intake or continuous alcohol intake or unable to
refrain from caffeine/alcohol consumption during hospitalization.
12. Current smoker (individuals who stopped smoking 3 months prior may be included in the
study) or unable to stop smoking from 3 months prior to the planned first IP dosing to
the last hospital discharge.
13. Having had any foods containing grapefruits from 24 hours prior to hospital admission
to discharge in each period/cohort and/or unable to refrain from having foods
containing grapefruits during the same period of time.
14. Unable to refrain from having foods containing caffeine (coffee, tea [black tea, green
tea, etc.], carbonated drink, coffee milk, nutrients and tonics, etc.) from 24 hours
prior to hospital admission to discharge in each period/cohort.
15. Individual or his spouse/partner who is unable to use medically acceptable methods of
contraception throughout the study plus for at least 3 months from the last IP dosing
and who does not agree not to donate sperm during the same period of time.
16. Ineligible for study participation in the opinion of the investigator for other
reasons including clinical laboratory test results.
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