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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01507051
Eligibility Criteria:
Inclusion Criteria:
* 18 to 45 years of age;
* Normal body weight: BMI (body mass index) between 18 and 29 kg/m2;
* Pharmacogenetics: subjects who are homozygous for the wildtype allele 2C9\*1 and who are carriers of the C-allele at positions 6484 and 7566 of the VKORC1 (vitamin K epoxide reductase) gene, respectively
Exclusion Criteria:
* Relevant deviation from the normal range in the clinical examination;
* Relevant deviation from the normal range in clinical chemistry, hematology or urinalysis;
* Resting heart rate in the awake subject below 45 BPM (beats per minute) or above 90 BPM;
* Systolic blood pressure below 100 mmHg or above 140 mmHg; and Diastolic blood pressure above 85 mmHg;
* Relevant pathological changes in the ECG (electrocardiogram) such as a second or third-degree AV block, prolongation of the QRS (QRS complex in ECG) complex over 120 msec or of the QT / QTc-interval over 450 msec (QT interval in ECG, QTc interval corrected for heart rate);
* Subject is tested to be HIV-1/2Ab, p24Ag, HbsAg or HCV-Ab positive;
* Known coagulation disorders (e.g. von Willebrand's disease, haemophiliac);
* Known disorders with increased bleeding risks (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer);
* Known sensitivity to common causes of bleeding (e.g. nasal);
* Recent or planned surgical or diagnostic procedures at the central nervous system (CNS) or eye;
* Subjects with hyperlipidemia (Coumadin / warfarin warning)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01507051
Study Brief:
Protocol Section:
NCT01507051