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This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects.
The objective of the study is to evaluate the effect of different meal types on the pharmacokinetics of DBPR108, a potent dipeptidylpeptidase-4 inhibitor. In this open-label, randomized, three-period, crossover study, healthy subjects will receive a single dose of DBPR108 100 mg under fasted conditions and following a low-fat meal or a standard meal. Twenty-one healthy subjects will be randomized 1:1:1 to Sequence A, Sequence B, or Sequence C. This study will consist of a screening and baseline period, a treatment period, and a follow-up period. Blood samples for pharmacokinetic assessments will be taken pre-dose and up to 48 h post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A administered DBPR108 | Experimental | Subjects will receive a single dose of DBPR108 100 mg under fasted condition, following a low-fat meal and a standard meal. |
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| Sequence B administered DBPR108 | Experimental | Subjects will receive a single dose of DBPR108 100 mg following a low-fat meal and standard meal, under fasted condition. |
|
| Sequence C administered DBPR108 | Experimental | Subjects will receive a single dose of DBPR108 100 mg following a standard meal, under fasted condition, following a low-fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBPR108 tablets | Drug | Drug: DBPR108, tablets, oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. | |
| Area under the plasma concentration versus time curve from time zero to the time of last measurable concentration (AUClast) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. | |
| Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve maximum plasma concentration (Tmax) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. | |
| Half-life (t1/2) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. |
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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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| ID | Term |
|---|---|
| C000718187 | DBPR108 |
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| Apparent clearance (CL/F) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. |
| Apparent volume of Distribution (Vz/F) of DBPR108 | Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9. |
| Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day 14 |