|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT04313205 |
|
Date of registration:
|
16/03/2020 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
|
|
Scientific title:
|
A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects |
|
Date of first enrolment:
|
August 2020 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04313205 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Contacts
|
|
Name:
|
Ying-Chu Shih, PhD |
|
Address:
|
|
|
Telephone:
|
+886-36587721 |
|
Email:
|
info@taiwanj.com |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Autoimmune Hepatitis
|
|
Intervention(s)
|
|
Drug: JKB-122 in capsule or tablet form
|
|
Primary Outcome(s)
|
|
Area under the curve from the time of dosing to steady state (AUC¬(0-t)ss¬¬)
[Time Frame: 2 WEEKS]
|
|
Secondary Outcome(s)
|
|
Number of Adverse events (AEs) observed
[Time Frame: 2 WEEKS]
|
|
Secondary ID(s)
|
|
TWJ-SR122
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|