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| Name | Class |
|---|---|
| BrightGene Pharmaceutical (Suzhou) Co., LTD | UNKNOWN |
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A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM0504 tablets | Experimental | Oral administration once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 tablets | Drug | Administered p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) endpoint: AUC0-tau,ss | 4 weeks | |
| PK endpoint:Cmax,ss | 4 weeks | |
| PK endpoint:t1/2,ss | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD) endpoint:Changes in fasting blood glucose | 6 weeks | |
| PD endpoint:waist circumference before and after administration | 6 weeks | |
| PD endpoint:body weight before and after administration |
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Inclusion Criteria:
○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;
Exclusion Criteria:
● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| 6 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks |
| Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 | 6 weeks |