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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00501267
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males \& females ages 18-65;
* Body weight \>50kg; BMI between 19-32;
* Signed and dated informed consent; QTc Interval \<450 msec;
Exclusion Criteria:
* Resting blood pressure \>140/90 mmHg or HR \>100 at screening;
* History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
* Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
* history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
* history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
* clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00501267
Study Brief:
Protocol Section:
NCT00501267