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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT01577459
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between 18 and 45 years of age, inclusive
* Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
* Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2
Exclusion Criteria:
* Systolic blood pressure \> 130 mmHg or \< 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Diastolic blood pressure \> 90 mmHg or \< 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Heart rate \> 90 bpm or \< 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
* Known allergy or hypersensitivity to PSE
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01577459
Study Brief:
Protocol Section:
NCT01577459