The First Hospital of Jilin University
Jilin City, Changchun, 130000, China
NCT Number: NCT05497674
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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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Jilin City, Changchun, 130000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral administration, single dose on Day 1 and Day 11
QD for 10 days
twice a day, for 5 days
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
To assess the effect of rifampicin on the AUC of rongliflozin
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
To assess the effect of rifampicin on the Cmax of rongliflozin
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
To assess the effect of probenecid on the AUC of rongliflozin
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
To assess the effect of probenecid on the Cmax of rongliflozin
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
To assess the effect of rifampicin and probenecid on the Tmax of rongliflozin
Time frame: from 0 hour to 5 days after rongliflozin dosing
evaluate the cumulative urine glucose excretion every 24 hours after rongliflozin administration.
Time frame: from screening to 3 days after last dose of rifampicin
To evaluate the safety and tolerability of single dose of rongliflozin and combination of rifampin
Time frame: from screening to 3 days after last dose of probenecid
To evaluate the safety and tolerability of single dose of rongliflozin and combination of probenecid
Sunshine Lake Pharma Co., Ltd.
Industry
A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules
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