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

• Status: Completed
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Probenecid; Rifampin

Criteria

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.