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TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQF3250 placebo | Placebo Comparator | Placebo without drug substance. |
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| TQF3250 capsule | Experimental | Oral administration, the fasting administration group was administered once, and the food-influenced group was administered once per cycle, for a total of two cycles. Each cycle is 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQF3250 placebo | Drug | TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) | Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs). | Up to 20 days |
| Number of participants with abnormal clinical laboratory test indicators | Number of participants with abnormal clinical laboratory test indicators. | Up to 20 days |
| Changes in body temperature after using TQF3250 capsules | Evaluate changes in body temperature after using TQF3250 capsules | Up to 24 hour |
| Tolerance assessment: 12-lead electrocardiogram | Tolerance assessment: 12-lead electrocardiogram | Up to 20 days |
| Changes in pulse/heart rate after use of TQF3250 capsules | Changes in pulse/heart rate after use of TQF3250 capsules | Up to 24 hour |
| Changes in respiratory rate after using TQF3250 capsules | Evaluate changes in respiratory rate after using TQF3250 capsules | Up to 24 hour |
| Changes in blood pressure after using TQF3250 capsules | To evaluate the changes in blood pressure after using TQF3250 capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Peak drug concentration (Cmax) | It refers to the highest blood concentration reached after administration of TQF3250 capsules. | Within 20 days after administration |
| Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Li, Doctor | Contact | 15951989771 | juanli2003@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drum Tower Hospital Affiliated to Nanjing University School of Medicine | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| TQF3250 capsule | Drug | TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects. |
|
| Up to 24 hour |
| Changes in blood oxygen saturation after using TQF3250 capsules | Evaluate changes in blood oxygen saturation after using TQF3250 capsules | Up to 24 hour |
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t). |
| Within 20 days after administration |
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) | Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞). | Within 20 days after administration |
| Peak time (Tmax) | It refers to the time it takes for TQF3250 capsules to reach the highest blood concentration after administration. | Within 20 days after administration |
| To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial | To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial. | Up to 20 days |
| To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial | To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial. | Up to 20 days |
| Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial | Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial. | Up to 20 days |
| Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites | Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites. | Up to 20 days |