Status:
UNKNOWN
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
Lead Sponsor:
TaiwanJ Pharmaceuticals Co., Ltd
Conditions:
Autoimmune Hepatitis
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
Detailed Description
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...
Eligibility Criteria
Inclusion
- The subject has a body mass index (BMI) range of 18.5 and \< 25.0 kg/m2 and weighs at least 50 kg.
- Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
- The subject provided written informed consent.
Exclusion
- Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
- 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.
- 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.
- Current smoker or history of smoking within 3 months before the Screening Visit.
- History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
- Any use of drugs-of-abuse within 3 months before the Screening Visit.
- Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
- Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
- Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
- The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04313205
Start Date
August 1 2020
End Date
December 1 2020
Last Update
July 15 2020
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