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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07533851
Enrollment
31
Registered
2026-04-16
Start date
2026-04-23
Completion date
2026-05-29
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief 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

Interventions

Oral administration after fasting/high-fat meal

Sponsors

Jiangsu vcare pharmaceutical technology co., LTD
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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. History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food ); 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;

Design outcomes

Primary

MeasureTime frame
Maximum Observed Plasma Concentration (Cmax)Day1-Day7
Area under the plasma concentration-time curve(AUC)Day1-Day7

Countries

China

Contacts

PRINCIPAL_INVESTIGATORbicheng Liu

Zhongda Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026