About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
Able to complete the study in compliance with the protocol;
Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 3 months after the last dose of study drug ;
Male and female subjects between the ages of 18 and 45 years, inclusive;
Disqualifiers
More than 5 cigarettes per day on average within 3 months prior to screening;
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;
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;
Donation or loss of a significant volume of blood (> 400 mL) within 3 months prior to screening;
Trial design
Single group
Treatments tested in this trial
VC005 and verapamil
DrugA single dose of VC005 was administered in the period 1. and a single dose of VC005 and verapamil coadministration in the period 2.
VC005 and probenecid
DrugA single dose of VC005 was administered in the period 1. and a single dose of VC005 and probenecid coadministration in the period 2.
VC005 and metformin
DrugA single dose of metformin was administered in the period 1. and a single dose of metformin and VC005 coadministration in the period 2
Treatment groups
Trial outcomes
Primary outcomes
Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC)
Sponsors and contacts
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