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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05569720
Eligibility Criteria:
Inclusion Criteria:
* Male or female (with no possibility to become pregnant (hysterectomized or menopausal women)) subjects who give their written consent to participate in the study.
* Aged from 18 to 55.
* No clinically significant organic or psychic conditions.
* No clinically significant abnormalities in medical records and physical examination.
* No clinically significant abnormalities in haematology, coagulation, biochemistry, serology and urinalysis .
* No clinically significant abnormalities in vital signs and electrocardiogram.
Exclusion Criteria:
* Subjects affected by an organic or psychic condition.
* Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication
* Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
* History of sensitivity to any drug.
* Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
* Smoker.
* Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
* Having donated blood in the last month before start of the study.
* Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
* Inability to follow the instructions or collaborate during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05569720
Study Brief:
Protocol Section:
NCT05569720