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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01005160
Eligibility Criteria:
Inclusion Criteria:
* Between 20 aged and 45 aged in healthy males
* Weight more than 55kg, IBW 20% within the range
* FPG 70\~125 mg/dL
* Agreement with written informed consent
Exclusion Criteria:
* Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
* Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
* Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
* AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
* systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
* Substance abuse, or a history of drug abuse showed a positive for the party
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Previously participated in other trial within 2 months
* Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
* Continued to be drunk or during clinical trials can not be drunk
* 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
* Containing grapefruit foods ingested during clinical trials or can not be ingested
* Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01005160
Study Brief:
Protocol Section:
NCT01005160