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This is a four-part, single-center, open-label, single-sequence crossover phase I clinical study to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 at steady-state with Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin in Healthy Subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin.
DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in four parts to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 with the expected concomitant drugs (Metformin hydrochloride, Glibenclamide, Valsartan, Simvastatin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 9), and a follow-up visit on Day 15. Approximately 14 subjects will be enrolled in each part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The DDI of DBPR108 tablets and Metformin hydrochloride tablets | Experimental | Subjects will receive a single dose of metformin hydrochloride on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of metformin hydrochloride on Day 8. |
|
| The DDI of DBPR108 tablets and Glibenclamide tablets | Experimental | Subjects will receive a single dose of Glibenclamide on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Glibenclamide on Day 8. |
|
| The DDI of DBPR108 tablets and Valsartan Capsules | Experimental | Subjects will receive a single dose of Valsartan on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Valsartan on Day 8. |
|
| The DDI of DBPR108 tablets and Simvastatin tablets | Experimental | Subjects will receive a single dose of Simvastatin on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Simvastatin on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBPR108 tablets | Drug | Drug: DBPR108, tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108 | Peak Plasma Concentration (Cmax) | Day 1 to Day 9 |
| The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108 | Area under the plasma concentration versus time curve (AUC) | Day 1 to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters | The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Tmax | Day 1 to Day 9 |
| The pharmacokinetic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Soochow University | Suzhou | China |
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| Metformin hydrochloride tablets | Drug | Drug: Metformin hydrochloride, tablet, oral |
|
| Glibenclamide tablets | Drug | Drug: Glibenclamide, tablet, oral |
|
| Valsartan Capsules | Drug | Drug: Valsartan, capsule, oral |
|
| Simvastatin tablets | Drug | Drug: Simvastatin, tablet, oral |
|
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : t1/2
| Day 1 to Day 9 |
| The pharmacokinetic parameters | The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Vz/F | Day 1 to Day 9 |
| The pharmacokinetic parameters | The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : CL/F | Day 1 to Day 9 |
| The number of volunteers with adverse events as a measure of safety and tolerability | The number of volunteers with adverse events as a measure of safety and tolerability | Day 1 to Day 15 |
| ID | Term |
|---|---|
| C000718187 | DBPR108 |
| D008687 | Metformin |
| D005905 | Glyburide |
| D000068756 | Valsartan |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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