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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJiangsu vcare pharmaceutical technology co., LTD

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • VC005 and verapamil

    Drug

    A 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

    Drug

    A 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

    Drug

    A 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

84 Participants
are divided into 3 treatment groups
Group A: VC005 and verapamilExperimental treatment 1 intervention
Group B: VC005 and probenecidExperimental treatment 1 intervention
Group C: VC005 and metforminExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Observed Plasma Concentration (Cmax)

Time frame
Day1-Day12
2

Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC)

Time frame
Day1-Day12

Secondary outcomes

Other outcomes

Sponsors and contacts

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