NCT05497674

Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects

A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Rongliflozin	oral administration, single dose on Day 1 and Day 11
DRUG	Rifampin	QD for 10 days
DRUG	Rongliflozin	oral administration, single dose on Day 1 and Day 6
DRUG	Probenecid	twice a day, for 5 days

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-07-22
• Completion: 2023-02-24
• First posted: 2022-08-11
• Last updated: 2023-03-01

Locations

1 site across 1 country: China