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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT01017003
Eligibility Criteria:
Inclusion Criteria:
* Completion of the screening process within 28 days prior to Period I dosing
* Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18 to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2
* Women must be postmenopausal, surgically sterile, commit to abstinence from heterosexual sexual contact or use two methods of contraception.
Exclusion Criteria:
* Pregnant or lactating
* Use of any investigational drug within 28 days prior to Period I dosing.
* Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)
* Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
* Clinical laboratory test values outside the accepted reference range and when confirmed on re-examination.
* Any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)
* Use of any systemic prescription medication in the 14 days prior to Period I dosing
* History of any allergy(s) including allergy to colchicine or related drugs.
* History of drug or alcohol addiction or abuse within the past year or a positive drug abuse screen
* Currently or recent (within 6 months) use of tobacco products prior to dose administration
* Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior to period I dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01017003
Study Brief:
Protocol Section:
NCT01017003