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

August 27, 2026 updated by: Jiangsu vcare pharmaceutical technology co., LTD

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Zhongda Hospital,Affiliated to Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC005 and verapamil
Drug: VC005 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.
Experimental: VC005 and probenecid
Drug: VC005 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.
Experimental: VC005 and metformin
Drug: VC005 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day1-Day12
Day1-Day12
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time Frame: Day1-Day12
Day1-Day12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Investigators

  • Principal Investigator: linlin Hu, Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC005-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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