Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02686294
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male in the age of 19-45
2. Body weight ≥ 50kg, BMI 18\~29 kg/m2
3. Subject who sign on an informed consent form willingly
Exclusion Criteria:
1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
2. Subject with acute disease within 28 days prior to study medication dosing
3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
4. Subject with clinically significant chronic disease
5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
6. Use of any prescription medication within 14 days prior to study medication dosing
7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
8. Subject with clinically significant allergic disease
9. Subject with known for hypersensitivity reaction to bepotastine
10. Subject with any of the following conditions in laboratory test
* AST/ALT \> UNL (upper normal limit) x 2
* Total bilirubin \> UNL x 2
* Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\]
* SBP\<100mmHg or ≥160mmHg, DBP\<60mmHg or ≥100mmHg
* QTc\>440msec on ECG
* Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L
11. Immunological incompetence, immune deficiency or taking immunosuppressants
12. Subject who cannot take standard meal
13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
14. Subject with blood transfusion within 30days prior to study medication dosing
15. Participation in any clinical investigation within 90days prior to study medication dosing
16. Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day)
17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
19. Subject who are not using adequate means of contraception
20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
21. Subject with history of drug abuse or drug addiction
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT02686294
Study Brief:
Protocol Section:
NCT02686294