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To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioequivalence study part | Experimental |
| |
| Food impact study part | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets | Drug | High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals. Low Specification Group: Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma | day 1 to day 18 | |
| PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma | day 1 to day 18 | |
| PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma | day 1 to day 18 | |
| The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax) | day 1 to day 18 | |
| The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax) | day 1 to day 18 | |
| The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t) | day 1 to day 18 | |
| The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞) | day 1 to day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent distribution volume (Vz/F) | day 1 to day 18 | |
| apparent clearance (CL/F) | day 1 to day 18 | |
| terminal phase half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Third Hospital | Changsha | Hunan | 410013 | 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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HRX0701 tablets are used alone, or Retagliptin phosphate tablets are used in combination with metformin hydrochloride tablets.
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|
| hrx0701 tablets | Drug | High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach). Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach). |
|
| day 1 to day 18 |
| retagliptin and metformin in plasma on fasting and after meals | day 1 to day 18 |
| The main metabolites of retagliptin acid PK parameters Cmax | day 1 to day 18 |
| The main metabolites of retagliptin acid AUC0-t | day 1 to day 18 |
| The main metabolites of retagliptin acid AUC0-∞ | day 1 to day 18 |
| Adverse events | day 1 to day 25 |
| D004700 | Endocrine System Diseases |