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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT01055834
Eligibility Criteria:
Inclusion criteria;
1. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will
2. Japanese healthy male adult volunteers
3. Participants who are between 20 and 54 years of age at the time of obtaining written consent
4. Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening
Exclusion criteria;
1. Participants with a present illness or history of allergy to drug or food, or seasonal allergy
2. Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
3. Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions
4. Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
5. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen
6. Participants who underwent blood transfusion within 12 weeks prior to, those whose 400 mL or more of whole blood was collected within 12 weeks prior to, or those whose 200 mL or more of whole blood was collected within 4 week prior to study drug administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
54 Years
Study:
NCT01055834
Study Brief:
Protocol Section:
NCT01055834