Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rongliflozin · 2 trials · 2 indications
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
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.
Proportion of different metabolites(Rongliflozin and main metabolites).
Radioactivity concentration in whole blood and plasma samples.
| 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. |
| [14C]- Rongliflozin | EXPERIMENTAL | Patients will receive single dose of \[14C\]- Rongliflozin (Suspension, 50mg/100μCi) |
| 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 |
| [14C]- Rongliflozin | DRUG | Patients will receive single dose of orally \[14C\]- Rongliflozin on Day 1 |
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 being studied for Type 2 Diabetes Mellitus and in healthy adult male volunteers. It is currently in Phase 1 clinical development and is not approved by the FDA.
Rongliflozin is being developed by Sunshine Biopharma Inc., a company listed on the NASDAQ under the ticker SBFM. The drug is currently in Phase 1 clinical trials.
Rongliflozin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for Rongliflozin have been completed.
Rongliflozin has been studied in two completed Phase 1 clinical trials: NCT05109078, an ADME study in healthy male subjects, and NCT05497674, a study of drug interactions in healthy subjects with Type 2 Diabetes Mellitus.
Rongliflozin is a distinct drug candidate developed by Sunshine Biopharma Inc. No alternative names for Rongliflozin have been identified in the available information.