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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01099904
Eligibility Criteria:
Inclusion Criteria:
* male or female adults, 18-75 years of age
* normal, or mildly or moderately impaired renal function (creatinine clearance \>/= 30 mL/min)
* BMI 18-40 kg/m2
* stable renal function
* agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
* agree to abstain from coffein consumption throughout study
Exclusion Criteria:
* positive urine or blood test for drugs of abuse not under a physician's prescription
* positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
* uncontrolled hypertension
* renal transplant, dialysis patient, nephritic syndrome
* clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01099904
Study Brief:
Protocol Section:
NCT01099904