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 @ 11:49 AM
Ignite Modification Date:
2025-12-24 @ 11:49 AM
NCT ID:
NCT03199261
Eligibility Criteria:
Inclusion Criteria:
* Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2，During Screening period body weight≥50 kg.
* Subjects are fully informed and voluntarily consent to participate in this study.
Exclusion Criteria:
* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
* History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
* History or presence neurological disorder disease.
* Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
* Participation in a clinical drug study 30 days prior to present study.
* FPG≥6.1mmol/L or \<3.9mmol/L.
* SBP\<90mmHg or \>140mmHg; DBP\>90mmHg.
* Use of any other drugs,vitamine and mineral substance.
* Blood donation more than 200 mL blood within 3 months prior to the study.
* Smoker (\>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
* History or Family history of hypoglycemia.
* History of allergy or hypersensitivity.
* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
* Other unfavorable factors diagnosed by investigators.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03199261
Study Brief:
Protocol Section:
NCT03199261