Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT05497674
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rongliflozin and/or rifampicin Rongliflozin 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. rongliflozin and/or probenecid Probenecid 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. rongliflozin and/or rifampicin Rifampin 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. rongliflozin and/or probenecid Rongliflozin 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.
- Primary Outcome Measures
Name Time Method rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone. from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing To assess the effect of rifampicin on the AUC of rongliflozin
rongliflozin:Cmax ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone. from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing To assess the effect of probenecid on the Cmax of rongliflozin
rongliflozin: AUC ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone. from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing To assess the effect of probenecid on the AUC of rongliflozin
rongliflozin: The peak concentration (Cmax) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone. from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing To assess the effect of rifampicin on the Cmax of rongliflozin
- Secondary Outcome Measures
Name Time Method the number of participants with adverse events (AE) in Cohort A 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
The time to peak (Tmax) of Rongliflozin. 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
pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours from 0 hour to 5 days after rongliflozin dosing evaluate the cumulative urine glucose excretion every 24 hours after rongliflozin administration.
the number of participants with adverse events (AE) in Cohort B 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
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Jilin, Changchun, China