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


Sunshine Lake Pharma

Status and phase

Phase 1


Type 2 Diabetes Mellitus


Drug: Rongliflozin
Drug: Rifampin
Drug: Probenecid

Study type


Funder types




Details and patient eligibility


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.


28 patients




18 to 45 years old


Accepts Healthy Volunteers

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 contraceptive measures from screening to 6 months after the last dose of drug administration;
  • Male subjects weigh at least 50 kg and female subjects at least 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI within the range of 18 to 28 kg/m2 ;
  • Physical examination and vital signs are both normal or do not have clinical significance.

Exclusion criteria

  • Smoking more than 5 cigarettes per day;
  • Those who are allergic to or have allergies to the test drug;
  • have a history of drug or alcohol abuse;
  • Blood donation or massive blood loss (>450 mL) within three months prior to screening;
  • Difficulty swallowing or any history of digestive system diseases which could affect drug absorption and excretion within 6 months before screening;
  • taking any drugs that could alter liver enzyme activity, such as barbiturates, rifampin, etc., within 30 days before screening;
  • have taken any prescription, over-the-counter, vitamin product or herbal medicine within 14 days prior to screening;
  • Have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 2 weeks before screening;
  • Take an inhibitor or inducer of glucuronide transferase (UGT), P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), such as itraconazole, ketoconazole, or dronedarone, within 30 days before screening;
  • Significant changes in dietary or exercise habits within 2 weeks prior to screening; Female subjects are breastfeeding or have a positive blood pregnancy result during the screening period;
  • During the screening period, the serum uric acid level was >420 µmol/l, or had a history of gout; during the screening period, the estimated glomerular filtration rate (eGFR) was <90 ml/min/1.73m2) or had a history of kidney stones or bladder stones (applicable to Cohort B);
  • have a clinically significant laboratory tests or medical history;
  • Positive for hepatitis B, hepatitis C, AIDS, syphilis; positive for urine drug test;
  • History of urinary tract infection or genital infection before 6 months
  • Those who participated in any drug clinical trial and used the experimental drug 3 months ago;
  • Subjects with other factors deemed inappropriate by the investigator.

Trial design

Primary purpose

Basic Science



Interventional model

Parallel Assignment


None (Open label)

28 participants in 2 patient groups

rongliflozin and/or rifampicin
Experimental group
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.
Drug: Rifampin
Drug: Rongliflozin
rongliflozin and/or probenecid
Experimental group
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.
Drug: Probenecid
Drug: Rongliflozin

Trial contacts and locations



Data sourced from clinicaltrials.gov

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