Drug-drug Interactions Studies of VC005 Tablets in Healthy Adult Subjects

A Clinical Trial of Drug-drug Interactions for VC005 Tablets in Healthy Adult Subjects

This study includes three groups of Drug-Drug Interaction( DDI ) studies:

1. To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
2. To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
3. To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.

Inclusion Criteria:

1. Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
2. Able to complete the study in compliance with the protocol;
3. Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 3 months after the last dose of study drug ；
4. Male and female subjects between the ages of 18 and 45 years, inclusive;
5. At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 19.0-26.0 kg/m2, inclusive;

Exclusion Criteria:

1. More than 5 cigarettes per day on average within 3 months prior to screening;
2. Subjects with a history of allergy, including allergy to drugs, food, dust mites, etc., or known hypersensitivity to drugs of the same class as the investigational product, or known hypersensitivity to verapamil, probenecid, metformin, or any of the excipients;
3. History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;
4. Donation or loss of a significant volume of blood (> 400 mL) within 3 months prior to screening;
5. History of difficulties in swallowing or any history of gastrointestinal, liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion；
6. Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;