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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03887858
Eligibility Criteria:
Inclusion Criteria:
1. Healthy subject older than 19 years men at the screening
2. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
\* BMI = Weight(kg)/ Height(m)2
5. Individuals who had agreed to participate in the study
6. Individuals without mental illness history within five year prior to the screening
7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption
8. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration
Exclusion Criteria:
1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
2. Individuals who had excessive drinking within the 1 month
\*Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
3. Individuals who had taken any medication within 10 days prior to the first day of dosing
4. Individuals who were deemed to be inappropriate to participate in the study by the investigator
5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
6. Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
9. Individuals with orthostatic hypotension
10. Individuals with severe hepatopathy
11. Individuals who had taken alpha-1 blocker
12. Individuals who had history of micturition syncope
13. Individuals with nephropathy
14. Elderly person
15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
16. Individuals who had taken CYP3A4 inhibitor
17. Individuals who had taken antihypertensive drug(s)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT03887858
Study Brief:
Protocol Section:
NCT03887858