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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02262858
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males according to the following criteria:
Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure, pulse rate), 12- lead ECG, clinical laboratory tests (including gastric acid (GA) test)
* No finding of clinical relevance
* No evidence of a clinically relevant concomitant disease
2. Age ≥ 20 years and Age ≤ 35 years
3. Body weight ≥ 50 kg
4. Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
5. Signed and dated written informed consent prior to admission to the study
Exclusion Criteria:
1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
7. Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test
8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
11. Smoker (20 or more cigarettes/day)
12. Inability to refrain from smoking during hospitalization
13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Any laboratory value outside the reference range that was of clinical relevance
18. Inability to comply with dietary regimen of study centre
19. Any other volunteers whom the investigator or sub investigator did not allow to participate in this study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT02262858
Study Brief:
Protocol Section:
NCT02262858