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The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Part A (single dose) | Experimental | Drug: GZR18 tablet Three single-dose cohorts of GZR18 tablet administered according to an ascending dose design. Progression to next dose will be based on safety evaluation. Sequential cohorts. Active Comparator: GZR18 injection Single-dose administered s.c. (under the skin). |
|
| Experimental: Part B (multiple dose) | Experimental | Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect. Parallel assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR18 | Drug | Oral administered the GZR18 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE and SAE | Incidence of Adverse Events and Severe Adverse Events | 22 days and 35 days |
| Relative bioavailability of GZR18 tablet | Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100% | 22 days and 35 days |
| ADA and NAb | Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) | 22 days and 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma drug concentration | 22 days and 35 days |
| AUC0-t | Area under the curve from 0 through the time of the last accurately measurable concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Min, Ph.D | Gan & Lee Pharmaceuticals Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 01 | Beijing | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 22 days and 35 days |
| AUC0-24h | Area under the curve from 0 h to 24 hours | 22 days and 35 days |
| D004700 | Endocrine System Diseases |