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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01780051
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male volunteers ages between 20 and 55 years at screening
2. Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight over 45kg
3. Signed informed consent with the date of signature
4. With ability to comply with all the scheduled visits, treatment plans; laboratory tests and other processes.
Exclusion Criteria:
1. Positive of blood, kidney, endocrine, lung, gastro-intestinal, cardiovascular, hepatic, psychiatric, nervous, allergy; or with past and present disease history or symptoms that are clinically significant.
2. Any conditions that are likely to affect drug absorption. ex) gastrectomy
3. Positive on urine drug tests
4. History of drinking alcohol more than 12 ounces(360mL) of beer, 1.5 ounces(45mL) of liquor; or 21 drinks/week(1drink = 5 ounces(150mL) of wine ) 6months prior to screening
5. Participation in any other clinical studies within 2months prior to scheduled study drug administration
6. With Blood pressure of ≥ 160 mmHg(Systolic blood pressure) or ≥ 90 mmHg(Diastolic blood pressure) in sitting position at screening time.
7. History of any serious substance or alcohol abuse within one year prior to screening
8. Use of any drugs known to significantly induce or inhibit drug metabolizing enzyme within 30days prior to scheduled study drug administration
9. Cigarette smoking of over 20 sticks per day.
10. Use of any prescription drugs or any over the counter drugs within 10days or quintuple half life(whichever is longer) prior to scheduled study drug administration
11. Donation of whole blood within 2months or any blood products within 1month, prior to scheduled study drug administration
12. Disability to comply with the guidelines written on the protocol
13. Severe acute/chronic medical, physical disorder or laboratory test abnormality that are likely to alter the study result and increase the risk by participating in the study and study drug administration
14. Hypersensitivity to chief component or excipient of Repaglinide
15. History of hypersensitivity to Metformin or Biguanide class of drugs
16. With renal failure or renal inadequacy caused by cardiovascular shock, acute myocardial infarction and sepsis
17. With Congestive heart failure and undergoing drug treatment.
18. Patients undergoing radioactive iodine uptake tests, such as intravenous urography, intravenous cholangiography, angiography, computed tomography using radioactive iodine
19. Patients with type 1 diabetes, acute or chronic metabolic acidosis including diabetic ketoacidosis associated with or without coma
20. With serious infection or trauma
21. Malnutrition, starvation; weakness; pituitary insufficiency or adrenal insufficiency
22. Patients with hepatic failure, pulmonary infarction, serious pulmonary dysfunction, or other conditions associated with hypoxemia, alcohol abuser, or dehydration, diarrhea; vomiting and gastro-intestinal disease
23. Proven to be unsuitable to participate in this clinical study by an investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01780051
Study Brief:
Protocol Section:
NCT01780051