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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
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This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
All subjects received the following drugs:
Phase 1-HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8); Phase 2-Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15); Phase 3-Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK16149 | Experimental | HSK16149(D1-D5) |
|
| Metformin | Experimental | Metformin |
|
| HSK16149+Metformin | Experimental | HSK16149+Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK16149 | Drug | HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8); |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak concentration | -30 minutes before administration until 24 hours after administration |
| AUC0-t, AUC0-∞ | Area under the concentration-time curve | -30 minutes before administration until 24 hours after administration |
| Tmax | time to peak observed | -30 minutes before administration until 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| AE/serious AE | Adverse event/serious adverse event | From screening up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Chen, PhD | Contact | 028-82378557 | chenk@haisco.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingxia Wang, PhD | Medical Ethics Committee of theThe fourth hospital of Hebei Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The fourth hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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|
| Metformin Hydrochloride tablet | Drug | Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15); |
|
|
| HSK16149+Metformin(phase 3) | Drug | Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach. |
|
|
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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