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This is a phase I, open-label, fixed-sequence study in healthy Chinese subjects, performed at a single study centre. Cohort A will assess the Pharmacokinetic (PK) profile of rongliflozin when administered alone and the combination with rifampicin; Cohort B will assess the PK profile of rongliflozin when administered alone and combination with probenecid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rongliflozin and/or rifampicin | Experimental | on Day 1, subjects will receive a single dose administration of rongliflozin, followed by a washout period of 4 days. Starting On Day 5, subjects will administer rifampicin once a day (QD) for 10 consecutive days ( Day 5 to Study Day 14) , comprising of a single dose administration of rongliflozin on Study Day 11. |
|
| rongliflozin and/or probenecid | Experimental | on Day 1, subjects will receive a single dose administration of rongliflozin, followed by a washout period of 4 days. Probenecid will be administrated twice a day from Day 5 to Day 9, and another single dose administration of rongliflozin on Day 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rongliflozin | Drug | oral administration, single dose on Day 1 and Day 11 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone. | To assess the effect of rifampicin on the AUC of rongliflozin | from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing |
| rongliflozin: The peak concentration (Cmax) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone. | To assess the effect of rifampicin on the Cmax of rongliflozin | from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing |
| rongliflozin: AUC ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone. | To assess the effect of probenecid on the AUC of rongliflozin | from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing |
| rongliflozin:Cmax ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone. | To assess the effect of probenecid on the Cmax of rongliflozin | from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The time to peak (Tmax) of Rongliflozin. | To assess the effect of rifampicin and probenecid on the Tmax of rongliflozin | from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing |
| pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | Changchun | 130000 | 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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| ID | Term |
|---|---|
| C000711712 | rongliflozin |
| D012293 | Rifampin |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin |
| Drug |
QD for 10 days |
|
| Rongliflozin | Drug | oral administration, single dose on Day 1 and Day 6 |
|
| Probenecid | Drug | twice a day, for 5 days |
|
evaluate the cumulative urine glucose excretion every 24 hours after rongliflozin administration. |
| from 0 hour to 5 days after rongliflozin dosing |
| the number of participants with adverse events (AE) in Cohort A | To evaluate the safety and tolerability of single dose of rongliflozin and combination of rifampin | from screening to 3 days after last dose of rifampicin |
| the number of participants with adverse events (AE) in Cohort B | To evaluate the safety and tolerability of single dose of rongliflozin and combination of probenecid | from screening to 3 days after last dose of probenecid |
| D004700 | Endocrine System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |