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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01373060
Eligibility Criteria:
Inclusion Criteria:
* Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive
Exclusion Criteria:
* Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
* Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
* Labo test results deviate from preset normal range
* Receiving treatment, including medication, within 14 days before the study
* Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
* Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
* Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
* Employed by the sponsor, delegated CRO or the study site
* Fasting plasma glucose level of \< 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
* Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01373060
Study Brief:
Protocol Section:
NCT01373060