A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
rongliflozin and/or rifampicin
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.
干预措施: Rongliflozin (Drug)
rongliflozin and/or rifampicin
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.
干预措施: Rifampin (Drug)
rongliflozin and/or 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.
干预措施: Rongliflozin (Drug)
rongliflozin and/or 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.
干预措施: Probenecid (Drug)
结局指标
主要结局
rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
To assess the effect of rifampicin on the Cmax of rongliflozin
次要结局
- the number of participants with adverse events (AE) in Cohort A(from screening to 3 days after last dose of rifampicin)
- The time to peak (Tmax) of Rongliflozin.(from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing)
- pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours(from 0 hour to 5 days after rongliflozin dosing)
- the number of participants with adverse events (AE) in Cohort B(from screening to 3 days after last dose of probenecid)