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:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT03309566
Eligibility Criteria:
Inclusion Criteria:
Male subjects between 18 and 55 years. Subjects with body mass index (BMI) between 19 and 27 kg / m². Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator.
Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.
Subjects who signed informed consent.
Exclusion Criteria:
Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.
Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic pressure in the first 3 minutes of postural change.
Active smoker more than 10 cigarettes / day. Pregnant or lactating women. Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).
Current clinical evidence of kidney disease. Current evidence of liver disorders Current clinical evidence of respiratory and heart diseases. The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.
Evidence of gastroduodenal disease. Current presence of any malignancy. History of abuse or addiction to drugs or alcohol during the past three years. Participation in a clinical trial within the last three months. Use of any drug within fourteen days before the start of the study. Subject donated or suffered blood loss during the last twelve weeks before the start of the study, or intends to donate blood within three months of the completion of the study.
Excessive drinking of tea, cocoa, mate, coffee and / or beverages containing caffeine (\> 5 cups / day) or wine (\> 0.5 L / day) or alcohol (\> 50 ml / day).
ECG abnormalities. Positive serology for HIV, hepatitis B or hepatitis C.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03309566
Study Brief:
Protocol Section:
NCT03309566