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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT01799603
Eligibility Criteria:
Inclusion Criteria:
* Be a Japanese man aged 20 to 40 years, inclusive at the day of informed consent being signed
* Must agree to use an adequate contraception method (for example, double-barrier method) as deemed appropriate by the Investigators during the study and for 3 months after receiving the last dose of study drug
* Body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2) and body weight not less than 50 kilogram
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* Non-smoker or participant who has quitted any tobacco or nicotine containing products more than one year prior to screening
Exclusion Criteria:
* History of or current clinically significant medical illness including (but not limited to), cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Use of any prescription or non-prescription medication (including vitamins and supplements) within 14 days before the administration on Day 1 of treatment Period 1
* History of drug or alcohol abuse within the past 5 years and positive test for drugs of abuse, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines or barbiturates and serum alcohol test
* Known allergy to the study drug or any of the excipients of the formulation
* Participated in another clinical study and received another study drugs administration or used an experimental medical device within 120 days or within a period less than 10 times the drug's half life, whichever is longer, before Day 1 of the first treatment period
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01799603
Study Brief:
Protocol Section:
NCT01799603