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Completed

NCT Number: NCT07533851

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongda Hospital,Affiliated to Southeast

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

VC005 tablets

Drug

Oral administration after fasting/high-fat meal

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day1-Day7

  2. Area under the plasma concentration-time curve(AUC)

    Time frame: Day1-Day7

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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