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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05881993
Eligibility Criteria:
Inclusion Criteria:
* Healthy non-pregnant female subjects
* Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
* Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
Exclusion Criteria:
* Screening blood pressure \< 100/60 mmHg or \> 140/90 mmHg
* Screening heart rate that is \< 40 bpm or \> 99 bpm
* Clinically significant ECG abnormality at screening
* Used prescription medication within 14 days prior to dosing
* Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
* Donated blood or had significant blood loss within 56 days prior to dosing
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05881993
Study Brief:
Protocol Section:
NCT05881993