Not Yet RecruitingPhase 1

A Food Effect Study of VC005 Tablets in Healthy Adult Subjects.

China30 participantsStarted 2026-04-30

Plain-language summary

This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect of VC005 Tablets in healthy subjects

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. More than 5 cigarettes per day on average within 3 months prior to screening;
✕. History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food );
✕. 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;

Maximum Observed Plasma Concentration (Cmax)

Timeframe: Day1-Day7

Area under the plasma concentration-time curve(AUC）

Timeframe: Day1-Day7

NCT IDNCT07533851

SponsorJiangsu vcare pharmaceutical technology co., LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-30

xiaojuan lai

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. More than 5 cigarettes per day on average within 3 months prior to screening;
✕. History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food );
✕. 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;