Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects (NCT06529445) | Clinical Trial Compass
CompletedPhase 1
Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects
China84 participantsStarted 2024-07-22
Plain-language summary
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect and Relative bioavailability of VC004 Capsules in healthy subjects
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 6 months after the last dose of study drug (see Appendix 5 for details);
✓. 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;
✕. with a history of allergies, including medication, food, mites, etc., or those known to be potentially allergic to drugs of the same class as the study drug;
✕. 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(such as reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion within 6 months prior to screening;
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax)
Timeframe: Day1-Day7
2
Peak time(Tmax)
Timeframe: Day1-Day7
3
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
✕. Those who Have taken strong inhibitors and / or inducers of liver metabolic enzymes (CYP1A2, 2A6, 2b6, 2c8, 2c19, 3A4 and 3A5) within 28 days prior to screening :strong inhibitors of liver metabolic enzymes such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, oleandomycin etc., strong inducers of liver metabolic enzymes such as rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc; Those who Have taken inhibitors and inducers of P-gp, MRPs, BCRP, OATP and other transporters and transporters within 28 days prior to screening; See Appendix 5 for details;
✕. Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to screening;
✕. Taking foods that affect CYP3A4 metabolism, such as grapefruit or drinks containing grapefruit within 2 weeks prior to screening, or taking high-intensity physical exercises (such as strength training, aerobic training and football playing) within 7 days prior to screening, or any other factors that affect drug absorption, distribution, metabolism and excretion;