Healthy Adult Participants
Conditions
Brief summary
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.
Interventions
DRUGVC005 and verapamil
A single dose of VC005 was administered in the period 1. and a single dose of VC005 and verapamil coadministration in the period 2.
DRUGVC005 and probenecid
A single dose of VC005 was administered in the period 1. and a single dose of VC005 and probenecid coadministration in the period 2.
DRUGVC005 and metformin
A single dose of metformin was administered in the period 1. and a single dose of metformin and VC005 coadministration in the period 2
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day1-Day12 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC） | Day1-Day12 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORlinlin Hu
Zhongda Hospital
Outcome results
None listed