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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01027169
Eligibility Criteria:
Inclusion Criteria:
* Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)
* Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing
* All subject have given written informed consent before any study-related activities are carried out
Exclusion Criteria:
* Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study
* Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility
* Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices \> grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance \< 50 mL/min calculated by use of Cockroft Gault formula)
* Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01027169
Study Brief:
Protocol Section:
NCT01027169