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Also known as [14C]- Rongliflozin
Rongliflozin · 1 trial · 1 indication
To assess the effect of rifampicin on the AUC of rongliflozin
To assess the effect of rifampicin on the Cmax of rongliflozin
To assess the effect of probenecid on the AUC of rongliflozin
To assess the effect of probenecid on the Cmax of rongliflozin
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Rongliflozin | DRUG | oral administration, single dose on Day 1 and Day 11 |
| Rifampin | DRUG | QD for 10 days |
| Probenecid | DRUG | twice a day, for 5 days |
Inclusion Criteria: * Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions; * Be able to complete the test according to the requirements of the protocol; * Subjects (including partners) are willing to take effective contracep...
Rongliflozin is an investigational small molecule drug being developed by Sunshine Biopharma Inc. (ticker SBFM) for Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial conducted in China. It is not approved for commercial use.
Rongliflozin is being developed for the treatment of Type 2 Diabetes Mellitus, a metabolic condition. Its clinical testing so far has involved healthy adult volunteers rather than patients with the disease. As an investigational agent in Phase 1, it has no approved therapeutic use.
Rongliflozin is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor behind the drug's clinical program in Type 2 Diabetes Mellitus.
Rongliflozin is in Phase 1 clinical development. It has one completed Phase 1 trial with 28 enrolled participants. The drug is investigational and has not been approved by the FDA or any other regulatory authority for the treatment of Type 2 Diabetes Mellitus.
Rongliflozin has been studied in one completed Phase 1 trial, NCT05497674, titled Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects. The trial enrolled 28 healthy adult volunteers in China and evaluated drug interaction effects on Rongliflozin pharmacokinetics.
Yes, [14C]-Rongliflozin is an alternative name for Rongliflozin. The 14C label refers to a carbon-14 radiolabeled form used in pharmacokinetic research. Both names refer to the same investigational small molecule developed by Sunshine Biopharma Inc. for Type 2 Diabetes Mellitus.