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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT00878618
Eligibility Criteria:
Inclusion Criteria:
* Healthy subject aged between 18 to 45 years inclusive
* Body mass index (BMI) between 19 to 30 kg/m2 inclusive
* Body weight between 50 to 100 kg inclusive
* Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.
Exclusion Criteria:
* Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
* Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
* History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
* Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00878618
Study Brief:
Protocol Section:
NCT00878618