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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
oral administration, single dose on Day 1 and Day 11
QD for 10 days
oral administration, single dose on Day 1 and Day 6
The First Hospital of Jilin University
Jilin City, Changchun, China
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing
The time to peak (Tmax) of Rongliflozin.
To assess the effect of rifampicin and probenecid on the Tmax of rongliflozin
Time frame: 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.
Time frame: from 0 hour to 5 days after rongliflozin dosing
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twice a day, for 5 days
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
Time frame: 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
Time frame: from screening to 3 days after last dose of probenecid