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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT02185066
Eligibility Criteria:
Inclusion Criteria:
1. Willing to adhere to protocol requirements and sign a informed consent form
2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
Exclusion Criteria:
1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
2. Symptom of an acute illness within 4 weeks prior to drug administration
3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. History of clinically significant allergies including drug allergies
6. History of clinically significant allergies about atorvastatin or metformin
7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
8. History of myopathy
9. Clinical laboratory test values are outside the accepted normal range
* AST or ALT \>1.25 times to normal range
* Total bilirubin \>1.5 times to normal range
* e-GFR \<90 mL/min
10. History of drug, caffein(caffein \> 5 cups/day), smoking (cigarette \> 10/day) or alcohol abuse(alcohol \> 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
11. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
12. Donated blood within 60 days prior to dosing
13. Participated in a previous clinical trial within 60 days prior to dosing
14. Use of any other medication, including herbal products, within 10 days before dosing
15. Subjects considered as unsuitable based on medical judgement by investigators
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT02185066
Study Brief:
Protocol Section:
NCT02185066