Healthy Adult ParticipantsPhase 1NCT07796191
Drug-drug Interactions Studies of VC005 Tablets in Healthy Adult Subjects
A Phase 1 study testing VC005 and verapamil, VC005 and probenecid and VC005 and metformin in people with Healthy Adult Participants, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- VC005 and verapamil, VC005 and probenecid and VC005 and metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- 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;
Who cannot join
- 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;
- 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；
- Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital,Affiliated to Southeast University
Nanjing, Jiangsu
linlin Hu, 13675132851, eliza50@sina.com
About this study
Official title: 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:
- To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.
- Conditions
- Healthy Adult Participants
- Being tested
- VC005 and verapamil, VC005 and probenecid, VC005 and metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 and verapamilDrug
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 probenecidDrug
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 metforminDrug
A single dose of metformin was administered in the period 1. and a single dose of metformin and VC005 coadministration in the period 2
| Study group | Role | What they receive |
|---|---|---|
| VC005 and verapamil | Experimental | Not described Receives: Drug: VC005 and verapamil |
| VC005 and probenecid | Experimental | Not described Receives: Drug: VC005 and probenecid |
| VC005 and metformin | Experimental | Not described Receives: Drug: VC005 and metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Day1-Day12
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Measured: Day1-Day12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- linlin Hu, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796191
- Sponsor's protocol ID
- VC005-110
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Drug-drug Interactions for VC005 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07796191
- Acronym / sponsor ID
- VC005-110
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study includes three groups of Drug-Drug Interaction( DDI ) studies:
- To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VC005 and verapamil | Experimental | Drug: VC005 and verapamil |
| VC005 and probenecid | Experimental | Drug: VC005 and probenecid |
| VC005 and metformin | Experimental | Drug: VC005 and metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
- 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;
Key exclusion criteria (6 listed)
- 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;
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC005 and verapamilA single dose of VC005 was administered in the period 1. and a single dose of VC005 and verapamil coadministration in the period 2. | Drug | VC005 and verapamil |
| VC005 and probenecidA single dose of VC005 was administered in the period 1. and a single dose of VC005 and probenecid coadministration in the period 2. | Drug | VC005 and probenecid |
| VC005 and metforminA single dose of metformin was administered in the period 1. and a single dose of metformin and VC005 coadministration in the period 2 | Drug | VC005 and metformin |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day1-Day12
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time frame: Day1-Day12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
linlin Hu principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VC005 and verapamil, VC005 and probenecid and VC005 and metformin in people with Healthy Adult Participants, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Day1-Day12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.