A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122
 capsules in healthy male subjects subjects.
This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover
 study in healthy male subjects. After screening, subjects will be randomized to receive
 either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods
 (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive
 JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a
 washout period.
Inclusion Criteria:

 1. The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at
 least 50 kg.

 2. Agreement for subject and female partner of childbearing potential to use acceptable
 method of contraception

 3. The subject provided written informed consent.

 Exclusion Criteria:

 1. Any history or evidence of any clinically significant major disease or malignancy, as
 judged by the Investigator.

 2. Any clinically significant abnormality following the Investigator's review of the
 physical examination, ECG and clinical study protocol-defined clinical laboratory
 tests.

 3. Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal
 remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.

 4. Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya,
 mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing
 these fruits in the 2 weeks prior to study drug administration.

 5. Current smoker or history of smoking within 3 months before the Screening Visit.

 6. History of drinking more than 21 units of alcohol per week within 3 months prior to
 the Screening Visit.

 7. Any use of drugs-of-abuse within 3 months before the Screening Visit.

 8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml
 within 3 months) prior to study drug administration.

 9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus
 antibodies (HCVAb) or human immunodeficiency virus.

 10. Participation in any clinical study or administration of any investigational product
 within 1 month of study drug administration.

 11. The subject has any other condition, which in the opinion of the Investigator
 precludes the subject's participation in the clinical study.