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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02838693
Eligibility Criteria:
Inclusion Criteria:
1. Ability to give informed consent
2. At least 30 years old, and not older than 65 years
3. Overtly healthy males or females, as determined by medical history, physical examination and laboratory results
4. Not on any regular medications. Subjects using traditional medicine concomitantly will also be excluded in this study
Exclusion Criteria:
1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
2. Known or ongoing psychiatric disorders within 3 years
3. Regularly use known drugs of abuse within 3 years
4. Women who are pregnant or lactating
5. Have donated blood of more than 500 mL within 4 weeks of study enrollment.
6. Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
7. Uncontrolled hypertension (blood pressure \[BP\] \>160/100mmHg
8. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
9. Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
10. Known allergy to insulin
11. History of bleeding diathesis or coagulopathy
12. Any of the following laboratory values at screening:
* LDL \> 190mg/dL (\>4.9mmol/L)
* TG \> 500mg/dL (\>5.6mmol/L)
* Hba1C \>= 6.5%
* Fasting glucose \>=126mg/dL(\>=7mmol/L) or 2 hour post-prandial glucose \>=200mg/dL (\>=11.1mmol/L)
* ALT \> 3.0 x upper limit of normal
* Estimated creatinine clearance \<60 mL/min
13. Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
14. Significant change in weight (+/- 5%) during the past month
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02838693
Study Brief:
Protocol Section:
NCT02838693