Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGRongliflozin
oral administration, single dose on Day 1 and Day 11
DRUGRifampin
QD for 10 days
DRUGProbenecid
twice a day, for 5 days
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
China
Outcome results
None listed