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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT01464450
Eligibility Criteria:
Inclusion Criteria:
* Healthy on the basis of physical examination, medical history, clinical laboratory tests, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening; Non-smoker for at least 3 months before screening; Women must be postmenopausal, surgically sterile or practicing a highly effective method of birth control; Men must agree to use birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug; Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg.; Be willing and able to adhere to the prohibitions and restrictions specified in this protocol;
Exclusion Criteria:
* History of or current clinically significant medical illness; Allergies, hypersensitivity, or intolerance to any component of rivaroxaban or its excipients or to Osmolite® 1.5 Cal; Contraindications to the use of anticoagulant (a drug used to thin blood) therapy (eg, bleeding diathesis, history of gastrointestinal (GI) bleeding within 1 year or coagulopathy); History of any disorder known to increase the risk of bleeding; Hepatic dysfunction and/or elevated serum transaminases; Clinically relevant hepatosplenomegaly as determined by the study investigator; Renal insufficiency; History of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence); Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before the planned first dose of study drug; Any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments; Had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study or within 12 weeks after the last dose of study agent is given; Uses any prescription or nonprescription medication (including vitamins and herbal supplements), except for (with restrictions) acetaminophen, oral contraceptives, and hormonal replacement therapy (stable dose) within 14 days before the first dose of the study drug is scheduled up to be given up to the End of Study/Early Withdrawal; History of drug or alcohol abuse within the past 2 years or a positive test for drugs of abuse at screening; Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before receiving the study drug or intention or donation of blood or blood products within 1 month before receiving the study drug, during the study or within 1 month after the completion of the study; Unable to swallow solid, oral dosage forms whole with the aid of water, crushed forms mixed with apple sauce or tolerate placement of a NG tube for delivery of drug suspension; Has a history of testing positive for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01464450
Study Brief:
Protocol Section:
NCT01464450