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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01050751
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).
Exclusion Criteria:
* Treatment with an investigational drug within 30 days or 5 half-lives or local regulation (whichever is longer) preceding the first dose of study medication.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* History of regular alcohol consumption exceeding 14 drinks/week for women and 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01050751
Study Brief:
Protocol Section:
NCT01050751