Atopic Dermatitis
Conditions
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day1-Day7 |
| Area under the plasma concentration-time curve(AUC) | Day1-Day7 |
Countries
China
Contacts
Zhongda Hospital