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Clinical Trial Details

Trial ID: L2291
Source ID: NCT05497674
Associated Drug: Rongliflozin
Title: Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Rongliflozin|DRUG: Rifampin|DRUG: Rongliflozin|DRUG: Probenecid
Outcome Measures: Primary: 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Sunshine Lake Pharma Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-02-21
Completion Date: 2023-02-24
Results First Posted:
Last Update Posted: 2023-03-01
Locations: The First Hospital of Jilin University, Jilin, Changchun, 130000, China
URL: https://clinicaltrials.gov/show/NCT05497674