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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT04027218
Eligibility Criteria:
Inclusion Criteria:
* Signed the informed consent form for bioequivalence study
* Signed the informed consent form for this clinical trial
* Fluid intake of participants was limited to a volume equal to or less than 500 ml
* Participants fasted 6-8 hours before venous cannulation
* Body mass index (BMI) between 18.5-29.9
* Vein perception by Venous International Assessment (VIA) scale between 5 to 2 grade.
Exclusion Criteria:
* Grade one in VIA scale
* Smokers
* BMI lower than 18.5 or equivalent or higher than 30
* Subjects who had any disease,
* Blood test, urinalysis, physical examination or electrocardiogram showing disorders with clinical relevance
* Subjects receiving treatment for anything apart from contraceptives.
* Gluten, lactose intolerance, vegetarian or vegan subjects for bioequivalence subjects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04027218
Study Brief:
Protocol Section:
NCT04027218