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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT01177150
Eligibility Criteria:
Inclusion Criteria:
* Have body mass index (BMI) between 20.0 and 29.9 kg/m2 inclusive
* Be a non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing products for at least 6 months prior to screening)
* Have competency in speaking and comprehending the language where the study will be conducted
Exclusion Criteria:
* Have history, or family history of bleeding or coagulation disorders or history of disorders that are potential causes of occult (test positive for fecal blood test without visible blood in feces) gastrointestinal bleeding
* Have currently active skin disorders
* Have history of renal or urinary tract diseases
* Have history of having chronically taken (daily administration for more than 7 days) oral steroids, topical iodine, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or other drugs known to interfere with blood clotting within 3 months of study start, or anticipates a need to take any of these during the course of the study
* Have history of recent major surgery (within 6 months of study start)
* Have history of recent travel (within 6 months) to locations that may predispose to the acquisition of communicable illnesses (e.g., parasitic or water-borne illnesses in developing tropical regions)
* Have recent history of alcohol or drug abuse within 6 months prior to screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01177150
Study Brief:
Protocol Section:
NCT01177150